[Federal Register: April 10, 1998 (Volume 63, Number 69)]
[Proposed Rules]
[Page 17744-17771]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ap98-27]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 26

[Docket No. 95N-0185]
RIN 0910-ZA11


Mutual Recognition of the Food and Drug Administration and
European Community Member State Conformity Assessment Procedures;
Pharmaceutical GMP Inspection Reports, Medical Device Quality System
Evaluation Reports, and Certain Medical Device Premarket Evaluation
Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations pursuant to an international agreement that is expected
to be concluded between the United States and the European Community
(EC) (Ref. 1). Under the terms of that agreement, FDA may normally
endorse good manufacturing practice (GMP) inspection reports for
pharmaceuticals provided by equivalent EC Member State regulatory
authorities and medical device quality system evaluation reports and
certain medical device premarket evaluation reports provided by
equivalent conformity assessment bodies. FDA is taking this action to
enhance its ability to ensure the safety and efficacy of
pharmaceuticals and medical devices through more efficient and
effective utilization of its regulatory resources. The agency is
requesting comments on the proposed rule.

DATES: Comments by May 11, 1998. Comments must be received by the
Dockets Management Branch (address below) by 4:30 p.m. Eastern Standard
Time on May 11, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857, fax 301-594-3215.

FOR FURTHER INFORMATION CONTACT: Merton V. Smith, Office of
International Affairs (HFG-1), Office of External Affairs, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
0910, or E-mail: ``MSmith@bangate.fda.gov''.

SUPPLEMENTARY INFORMATION:

I. Background and History

    On June 20, 1997, the United States and the EC concluded
negotiations of an agreement entitled ``Agreement on Mutual Recognition
between the United States of America and the European Community'' (also
called ``the MRA''). The MRA includes two sectoral annexes covering
products regulated by FDA. The medical device sectoral annex covers
medical device quality system-related inspection reports and premarket
evaluation reports. The pharmaceutical GMP sectoral annex covers
pharmaceutical GMP inspection reports. The MRA also includes sectoral
annexes covering products regulated by other U.S. regulatory agencies,
including telecommunication equipment, electromagnetic compatibility,
electrical safety, and recreational craft. Finally, the MRA includes an
``umbrella'' agreement that contains general provisions applicable

[[Page 17745]]

to the operation of all of the sectoral annexes.
    At the conclusion of negotiations, the United States and the EC
agreed to submit the text of the MRA to their respective authorities to
complete the necessary procedures for approval and implementation (Ref.
2). For FDA, the procedures include publishing this proposed rule for
public comment.
    In this document, FDA has published relevant provisions of the two
FDA sectoral annexes and the umbrella agreement, some of which create
binding obligations. FDA will review all comments and will consider
those comments addressing its binding obligations under the agreement.

II. Statutory Authority

    FDA has the authority to enter into and execute the MRA under the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321 et seq.)
and the Public Health Service Act (the PHS Act) (42 U.S.C. 201 et
seq.). For drugs and medical devices, section 510(i)(3) of the act (21
U.S.C. 360(i)(3)) provides authority for FDA to enter into the MRA.
Section 510(i)(3) of the act provides that:
    The Secretary [FDA by delegation] is authorized to enter into
cooperative arrangements with officials of foreign countries to
ensure that adequate and effective means are available for purposes
of determining, from time to time, whether drugs or devices
manufactured, prepared, propagated, compounded, or processed by an
establishment * * * [described in this section], if imported or
offered for import into the United States, shall be refused
admission on any of the grounds set forth in section 801(a).
(Ref. 3).
    The MRA and the pharmaceutical and medical device annexes represent
cooperative arrangements with officials from foreign countries. The
purpose of these arrangements is, among other things, to ensure FDA has
adequate and effective means to determine whether drugs or devices
offered for import are adulterated, misbranded, or in violation of
section 505 of the act (21 U.S.C. 355) (Ref. 4). FDA's authority to
make these determinations is found at section 801(a) of the act (21
U.S.C. 381(a)).
    Section 803(b) of the act (21 U.S.C. 383(b)) provides FDA with
authority to enter into the medical device sectoral annex. That section
authorizes FDA to enter into agreements with foreign countries to
facilitate commerce in medical devices, consistent with the provisions
of the act. Such agreements are to encourage the mutual recognition of
GMP regulations relating to devices, as well as other regulations and
testing protocols determined by the Secretary (FDA by delegation) to be
appropriate.
    Additional support for FDA authority to enter into this MRA is
found in the PHS Act. Under section 307 of the PHS Act (42 U.S.C.
242l), the Secretary of Health and Human Services (FDA by delegation)
has authority ``to participate with other countries in cooperative
endeavors'' in biomedical research and health care technology. In
addition, the Secretary of Health and Human Services (FDA by
delegation) has authority under section 301 of the PHS Act (42 U.S.C.
241) to ``cooperate with, and render assistance to other appropriate
public authorities * * * in the conduct of * * * investigations * * *
relating to the * * * prevention of physical and mental diseases and
impairments of man * * * .'' The cooperative activities between FDA and
the EC set forth in the MRA and this proposed regulation, fall within
FDA's delegated authority under these sections of the PHS Act.
    Finally, a provision of the recently enacted FDAMA provides
authority for FDA to participate in MRA activities. Section 410 of
FDAMA authorizes FDA to ``support the Office of the United States Trade
Representative, in consultation with the Secretary of Commerce, in
efforts to move toward the acceptance of mutual recognition agreements
relating to the regulation of drugs, biological products, [and] devices
* * * and the regulation of good manufacturing practices, between the
European Union and the United States'' (Ref. 5). During negotiation of
this MRA, officials from FDA, the Office of the United States Trade
Representative, and the Department of Commerce participated in
activities in an effort to move toward acceptance of a mutual
recognition agreement.

III. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, under the Regulatory Flexibility Act (Pub. L. 96-354, as
amended by Pub. L. 104-121), and under the Unfunded Mandates Reform Act
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The Unfunded Mandates Reform Act requires agencies
to prepare an assessment of anticipated costs and benefits before
enacting any rule that may result in an expenditure by State, local and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 (adjusted annually for inflation) in any one year.
    The agency believes that this proposed rule is consistent with the
regulatory philosophy and principles identified in the Executive Order
and in these two statutes. Through this regulation, the agency is
proposing to set out requirements through which it may normally endorse
certain conformity assessment procedure reports. Such reports would be
provided by equivalent EC Member State regulatory authorities for
manufacturing site inspections to ascertain conformity with
pharmaceutical GMP's and by equivalent conformity assessment bodies for
quality system audits and certain medical device premarket evaluations.
Obtaining conformity assessment information in the manner described in
the proposed rule is inherently more efficient and cost-effective than
the existing approach, where additional inspection efforts by FDA in
foreign countries are necessary because foreign regulatory systems have
not been found equivalent. The primary benefit of the proposed rule is
to provide credible assurance that the rapidly increasing volume of EC
Member States' imports into the United States meet pharmaceutical GMP
requirements, and medical device quality system evaluation and certain
premarket evaluation requirements, as specified in U.S. statutes and
regulations. In the future, this credible assurance must be achievable
without resource expenditures by FDA that are directly proportional to
the volume of trade.
    In recent years, the credibility of the current approach has been
strained as FDA's essentially constant foreign inspection capacity has
been stretched over an expanding volume of imports from the EC. In the
3-year interval between 1994 and 1997, the value of EC pharmaceutical
and medical device imports into the United States has nearly doubled
from $5.5 billion to more than $10.7 billion. Growth has been greatest
in pharmaceuticals, where

[[Page 17746]]

annual EC exports have increased by more than $2 billion in each of the
last 2 years. In 1997, FDA conducted one inspection in the EC for every
$60 million in pharmaceutical exports to the United States, which is
less than half the coverage intensity of 1994. In addition, the
majority of these inspections have been preapproval in nature.
Continuation of the current trend will further decrease FDA's coverage
intensity to less than one inspection per $100 million in EC
pharmaceutical exports by the year 2000. Equivalence with EC Member
State regulatory systems has the potential for leveraging FDA's
regulatory resources so that necessary conformity assessments can be
ensured for higher volumes of future trade.
    In addition to coping with higher trade volumes, mutual recognition
or equivalence-based agreements with exporting nations may permit FDA
to redirect some of its inspectional resources to risk priorities not
covered by such agreements. This flexibility would provide a more
responsive level of U.S. consumer protection in the face of a changing
global marketplace with inherently variable risk management priorities.
    Another important benefit of the proposed rule would be the cost
savings realized by the regulated industry, largely as a result of
sharing inspection reports among equivalent regulatory authorities.
This exchange, in turn, will eliminate the need for duplicative
inspections and permit individual firms to undergo fewer inspections of
manufacturing sites. FDA does not have data on the average
administrative cost incurred by pharmaceutical (including biological)
or medical device manufacturers as they participate in regulatory
inspections, but it is reasonable to assume that the avoidance of
redundant inspections would generate cost savings. The proposed rule
also may shorten product review times for regulated products as a
result of the increased efficiency of premarket approval inspection
activities and the third-party evaluation of certain medical devices.
Quantification of this savings will be highly dependent on the specific
countries that achieve equivalence and the number of medical device
audits and evaluations performed by conformity assessment bodies.
    The costs of this regulation appear to impact more directly on
governmental regulatory agencies than on the regulated industry. These
governmental costs involve both startup and operational components. FDA
has not received additional government funding earmarked for achieving
mutual recognition agreements. FDA, therefore, must proceed to
implement these agreements as a concurrent function within normal day-
to-day regulatory activities. The 3-year transition period reflects the
necessity to absorb these startup costs within existing regulatory
budgets. Some activities such as joint inspections may be reasonably
easy to absorb as concurrent functions that do not require additional
funding, while others such as developing and maintaining systems for
routine information exchange may involve new activities. These absorbed
governmental costs will fall heavily on FDA, as it must assess
equivalence of multiple EC Member States and notified bodies.
    For FDA, the absorption of these startup costs will be easier with
respect to those EC Member States with a large volume of trade, where
FDA already conducts enough inspections to gather a general
understanding of the requirements and regulatory practices of the
exporting country. From this perspective, the pace and priorities for
mutual recognition agreements during the transition period may be
dictated by FDA's ability to conduct these processes as concurrent
functions within current activities.
    In the longer run, an operational system of mutual recognition
agreements could pose additional costs on regulatory authorities of
exporting countries if equivalence requires a frequency, focus or
content of inspections not presently included in regulatory
requirements of the exporting nation. For example, Country A may not be
able to provide the frequency of medical device inspections desired by
Country B without conducting inspections beyond those required for
Country A's domestic inspection strategy. Conversely, Country B may not
be able to provide to Country A adequate details of the quality of
pharmaceutical source materials, because Country B does not have
inspectional authority over pharmaceutical starting materials. To the
extent such costs are insignificant or offset by other savings, they
will not likely be obstacles to reaching agreement on equivalence.
    This proposal is not expected to involve any new incremental costs
to the affected industry. Although joint inspections during the
transition period may create the appearance of more regulatory effort,
they should not impose additional costs on the firms inspected. FDA
does not anticipate an increase in the total number of inspections, and
in fact, the coverage intensity of FDA inspections in the EC would
continue to fall during the transition period, as it has been for the
past several years. Other activities related to equivalence
determinations, such as the procedures for exchanging information and
reports, focus on the interface and coordination between regulatory
agencies and, as such, do not affect industry in a cost context.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities unless the rule is not expected to have a significant
impact on a substantial number of small entities. As the proposed
regulation is not expected to impose costs on the regulated industry,
the agency certifies that the proposed rule would not have a
significant impact on a substantial number of small entities.
Therefore, under the Regulatory Flexibility Act, no further analysis is
required.
    The Unfunded Mandates Act of 1995 requires that agencies prepare an
assessment of the anticipated costs and benefits before issuing any
final rule that may result in expenditures by State, local, and tribal
governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one year.
This proposed rule does not impose any mandates on State, local or
tribal governments, or the private sector that would result in an
annual expenditure of $100,000,000 or more. Therefore, no further
analysis is appropriate for this requirement.

V. Paperwork Reduction Act of 1995

    This proposed rule does not contain any information collection
provisions that would be subject to review by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520).

VI. Request for Comments

    Interested persons may, on or before May 11, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this proposed regulation. Comments must be received by the Dockets
Management Branch by 4:30 p.m. Eastern Standard Time May 11, 1998. Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments, a
copy of the MRA, and a summary explanation of the MRA's provisions, to
aid in commenting, may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday. In addition, an electronic copy of the MRA
and the summary

[[Page 17747]]

explanation is available on FDA's web site at ``http://www.fda.gov''
under the ``international'' heading menu item.
    The comment period in this document is shorter than the 60 days FDA
customarily provides for proposed rules (21 CFR 10.40(b)(2)). FDA
believes it is unnecessary to provide 60 days for comment, given the
opportunities for public comment the agency already has provided.
During the course of the negotiations of the MRA, FDA provided a number
of opportunities for public discussion. For example, on May 9, 1996 (61
FR 21194), FDA established a public docket for information concerning
the MRA (Ref. 6). In addition, on October 18, 1996, FDA made available
for public comment copies of a document entitled, ``FDA Proposal for an
Agreement With the European Union Concerning the Mutual Recognition of
Inspections to Determine Adherence to Manufacturing Practices for
Pharmaceuticals Including Biologicals.'' FDA formally sought public
comment on this proposal through a Federal Register notice (61 FR
54448, October 18, 1996). To provide opportunity for public input into
the pharmaceutical GMP discussions with the European Commission, FDA
hosted public exchange meetings in Washington, DC, and Rockville, MD,
on March 31, 1995 (see 60 FR 15934, March 28, 1995), and October 30,
1996 (see 61 FR 54448, October 18, 1996). On November 8 and 9, 1996, a
transatlantic business dialogue (TABD) meeting included an extensive
discussion of the unresolved issues for the pharmaceutical and medical
device annexes to the MRA (Ref. 7), and on March 14, 1997, FDA
participated in a meeting of U.S. agencies and nongovernmental
organizations, which included several consumer, industry, and
environmental groups. Finally, FDA provided information and solicited
comment on the MRA at a September 23, 1997, National Consumer Forum
held in Washington, DC. The purpose of the forum was to facilitate
dialogue on the MRA between FDA and consumers.
    In light of the extensive opportunities for public participation,
FDA believes there is good cause to provide 30 days for comment on this
proposed rule. The agency also believes it is in the public interest to
proceed expeditiously to implement the MRA, so that it can proceed
toward the anticipated resource efficiencies and enhancement of product
safety, effectiveness, and quality that the MRA can provide. The 30-day
comment period provides sufficient opportunity to receive and consider
comments before the anticipated signing of the MRA in late spring or
early summer.
    The agency also notes that the comment period is less than that
required by Executive Order 12889 (58 FR 69681, December 30, 1993).
Section 4 of Executive Order 12889 states that any agency subject to
the Administrative Procedure Act shall provide a 75-day comment period
for any proposed technical regulation. Because this proposed rule
creates no new technical obligations or mandatory requirements on the
public, FDA believes that it is not a technical regulation subject to
Section 4 of Executive Order 12889. As a result, a 75-day comment
period is not required for this proposed rule.

VII. References

    1. The European Community consists of the following member
States: Austria, Belgium, Denmark, Finland, France, Germany, Greece,
Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain,
Sweden, and the United Kingdom. These countries have vested in the
European Commission the authority to conduct certain international
negotiations, on their behalf, with other countries such as the
United States.
    2. On June 20, 1997, U.S. Trade Representative Charlene
Barshefsky and European Commission Vice President Leon Brittan
signed ``Agreed Minutes on the Agreement on Mutual Recognition
between the United States of America and the European Community,''
which states that the MRA ``represents the text we commit to submit
to our respective authorities with a view to completing the
necessary procedures for approval and implementation.'' The complete
text of the MRA is available on the Internet at FDA's web site,
``http://www.fda.gov'', under the ``international'' menu item or on
the European Community web site, ``http://europa.eu.int/en/comm/
dg01/mra03.htm''.
    3. Food and Drug Administration Modernization Act of 1997
(FDAMA), section 417, Pub. L. 105-115, 111 Stat. 2296 (1997) (to be
codified at 21 U.S.C. 360(i)(3)).
    4. Provisions in the act that govern FDA regulation of
pharmaceuticals and medical devices include sections 501, 502, 505,
512, 513, 520, and 522 (21 U.S.C. 351, 352, 355, 360b, 360c, 360j,
and 360l).
    5. FDAMA section 410 (to be codified at 21 U.S.C. 383(c)(2)).
    6. Information in the docket includes summaries of minutes of
the meetings described in this document with written comments
received from interested parties, summaries of the various
negotiation sessions between FDA and the European Commission and EC
Member State representatives, and copies of draft agreements
covering pharmaceutical GMP's and medical devices that were
exchanged between the EC and FDA in December 1996 and January 1997.
    7. The TABD is an industry-driven initiative that aims to
facilitate closer economic relations between the EC and the United
States.

VIII. Comparison Table

    The following table shows the relationship of the MRA Articles and
the sections of the Code of Federal Regulations (CFR) as proposed under
this rule:

    Table 1.--Relationship of the MRA Articles to sections in the CFR
------------------------------------------------------------------------
                MRA Article                          CFR Section
------------------------------------------------------------------------
  Sectoral Annex for Pharmaceutical GMP's              Subpart A
------------------------------------------------------------------------
Article 1.................................  26.1
Article 2.................................  26.2
Article 3.................................  26.3
Article 4.................................  26.4
Article 5.................................  26.5
Article 6.................................  26.6
Article 7.................................  26.7
Article 8.................................  26.8
Article 9.................................  26.9
Article 10................................  26.10
Article 11................................  26.11
Article 12................................  26.12
Article 13................................  26.13
Article 14................................  26.14
Article 15................................  26.15
Article 16................................  26.16
Article 17................................  26.17
Article 18................................  26.18
Article 19................................  26.19
Article 20................................  26.20
Article 21................................  26.21
Appendix 1................................  Appendix A
Appendix 2................................  Appendix B
Appendix 3................................  Appendix C
Appendix 4................................  Appendix D
Appendix 5................................  Appendix E
------------------------------------------------------------------------


------------------------------------------------------------------------
                MRA Article                          CFR Section
------------------------------------------------------------------------
     Sectoral Annex on Medical Devices                Subpart B
------------------------------------------------------------------------
Article 1.................................  26.31
Article 2.................................  26.32
Article 3.................................  26.33
Article 4.................................  26.34
Article 5.................................  26.35
Article 6.................................  26.36
Article 7.................................  26.37
Article 8.................................  26.38
Article 9.................................  26.39
Article 10................................  26.40
Article 11................................  26.41
Article 12................................  26.42
Article 13................................  26.43
Article 14................................  26.44
Article 15................................  26.45
Article 16................................  26.46
Article 17................................  26.47
Article 18................................  26.48
Article 19................................  26.49
Article 20................................  26.50
Appendix 1................................  Appendix A

[[Page 17748]]


Appendix 2 and Tables 1-3.................  Appendix B and Tables 1-3
Appendix 3 [Reserved].....................  Appendix C [Reserved]
Appendix 4 [Reserved].....................  Appendix D [Reserved]
Appendix 5 [Reserved].....................  Appendix E [Reserved]
Appendix 6 [Reserved].....................  Appendix F [Reserved]
------------------------------------------------------------------------


------------------------------------------------------------------------
                MRA Article                          CFR Section
------------------------------------------------------------------------
            Umbrella Agreement                        Subpart C
------------------------------------------------------------------------
Article 1.................................  26.60
Article 2.................................  26.61
Article 3.................................  26.62
Article 4.................................  26.63
Article 5.................................  26.64
Article 6.................................  26.65
Article 7.................................  26.66
Article 8.................................  26.67
Article 9.................................  26.68
Article 10................................  26.69
Article 11................................  26.70
Article 12................................  26.71
Article 13................................  26.72
Article 14................................  26.73
Article 15................................  26.74
Article 16................................  26.75
Article 17................................  26.76
Article 18................................  26.77
Article 19................................  26.78
Article 20................................  26.79
Article 21................................  26.80
Article 22................................  26.81
------------------------------------------------------------------------

List of Subjects in 21 CFR Part 26

    Animal and human drugs, Biologicals, Devices, Exports, Imports,
Incorporation by reference, and Inspections.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR chapter I be
amended by adding part 26 to read as follows:

PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING
PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND
CERTAIN MEDICAL DEVICE PREMARKET EVALUATION REPORTS PROVIDED BY
EUROPEAN COMMUNITY MEMBER STATE REGULATORY AUTHORITIES AND EUROPEAN
COMMUNITY CONFORMITY ASSESSMENT BODIES

Sec.
26.0 General.

Subpart A--Specific Sector Provisions for Pharmaceutical Good
Manufacturing Practices

26.1 Definitions.
26.2 Purpose.
26.3 Scope.
26.4 Product coverage.
26.5 Length of transition period.
26.6 Equivalence assessment.
26.7 Participation in the equivalence assessment and determination.
26.8 Other transition activities.
26.9 Equivalence determination.
26.10 Regulatory authorities not listed as currently equivalent.
26.11 Start of operational period.
26.12 Nature of recognition of inspection reports.
26.13 Transmission of postapproval inspection reports.
26.14 Transmission of preapproval inspection reports.
26.15 Monitoring continued equivalence.
26.16 Suspension.
26.17 Role and composition of the Joint Sectoral Committee.
26.18 Regulatory collaboration.
26.19 Information relating to quality aspects.
26.20 Alert system.
26.21 Safeguard clause.
Appendix A of Subpart A--List of Applicable Laws, Regulations, and
Administrative provisions.
Appendix B of Subpart A--List of Authorities.
Appendix C of Subpart A--Indicative List of Products Covered by
Subpart A.
Appendix D of Subpart A--Criteria for Assessing Equivalence for
Post- and Preapproval.
Appendix E of Subpart A--Elements to be Considered in Developing a
Two-way Alert System.

Subpart B--Specific Sector Provisions for Medical Devices

26.31 Purpose.
26.32 Scope.
26.33 Product coverage.
26.34 Regulatory authorities.
26.35 Length and purpose of transition period.
26.36 Listing of CAB's.
26.37 Confidence building activities.
26.38 Other transition period activities.
26.39 Equivalence assessment.
26.40 Start of the operational period.
26.41 Exchange and endorsement of quality system evaluation reports.
26.42 Exchange and endorsement of product evaluation reports.
26.43 Transmission of quality system evaluation reports.
26.44 Transmission of product evaluation reports.
26.45 Monitoring continued equivalence.
26.46 Listing of additional CAB's.
26.47 Role and composition of the Joint Sectoral Committee.
26.48 Harmonization.
26.49 Regulatory cooperation.
26.50 Alert system and exchange of postmarket vigilance reports.
Appendix A of Subpart B--Relevant Legislation, Regulations and
Procedures
Appendix B of Subpart B--Scope of Product Coverage
Appendix C of Subpart B [Reserved]
Appendix D of Subpart B [Reserved]
Appendix E of Subpart B [Reserved]
Appendix F of Subpart B [Reserved]

Subpart C--Framework or ``Umbrella'' Provisions

26.60 Definitions.
26.61 Purpose of this part.
26.62 General obligations.
26.63 General coverage of this part.
26.64 Transitional arrangements.
26.65 Designating authorities.
26.66 Designation and listing procedures.
26.67 Suspension of listed conformity assessment bodies.
26.68 Withdrawal of listed conformity assessment bodies.
26.69 Monitoring of conformity assessment bodies.
26.70 Conformity assessment bodies.
26.71 Exchange of information.
26.72 Sectoral contact points.
26.73 Joint Committee.
26.74 Preservation of regulatory authority.
26.75 Suspension of recognition obligations.
26.76 Confidentiality.
26.77 Fees.
26.78 Agreements with other countries.
26.79 Territorial application.
26.80 Entry into force, amendment and termination.
26.81 Final provisions.
    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 351,
352, 355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h, 360i, 360j,
360l, 371, 374, 381, 382, 383, 393; 42 U.S.C. 216, 241, 242l, 262,
264, 265.

Sec. 26.0  General.

    This part substantially reflects relevant provisions of the
proposed international agreement entitled, ``Agreement on Mutual
Recognition Between the United States of America and the European
Community'' (the MRA), including the ``umbrella'' text and its sectoral
annexes on pharmaceutical good manufacturing practices (GMP's) and
medical devices. Whereas the parties to the MRA would be the United
States and the European Community (EC), this part is relevant only to
the Food and Drug Administration's (FDA's) implementation of the MRA
and the

[[Page 17749]]

sectoral annexes cited in this section. For codification purposes,
certain provisions of the MRA have been modified for use in this part.
This modification is done for purposes of clarity only and shall not
affect the text of the MRA to be concluded between the United States
and the EC, or the rights and obligations of the United States or EC
under that agreement. References to the terms ``party'' or ``parties''
reflect FDA's proposed implementation of the MRA and its sectoral
annexes. It is understood that the EC will also be a party to the MRA
and that it will implement the MRA in accordance with its internal
procedures. If the parties to the MRA subsequently amend or terminate
the MRA, FDA will modify this part accordingly, using appropriate
administrative procedures.

Subpart A--Specific Sector Provisions for Pharmaceutical Good
Manufacturing Practices

Sec. 26.1  Definitions.

    (a) Enforcement means action taken by an authority to protect the
public from products of suspect quality, safety, and efficacy or to
assure that products are manufactured in compliance with appropriate
laws, regulations, standards, and commitments made as part of the
approval to market a product.
    (b) Equivalence of the regulatory systems means that the systems
are sufficiently comparable to assure that the process of inspection
and the ensuing inspection reports will provide adequate information to
determine whether respective statutory and regulatory requirements of
the authorities have been fulfilled. Equivalence does not require that
the respective regulatory systems have identical procedures.
    (c) Good Manufacturing Practices (GMP's): [These GMP conceptual
definitions are to be merged by the parties at a future date.]
    (1) GMP's mean the requirements found in the respective
legislations, regulations, and administrative provisions for methods to
be used in, and the facilities or controls to be used for, the
manufacturing, processing, packing, and/or holding of a drug to assure
that such drug meets the requirements as to safety, and has the
identity and strength, and meets the quality and purity characteristics
that it purports or is represented to possess.
    (2) GMP's are that part of quality assurance which ensures that
products are consistently produced and controlled to quality standards.
For the purpose of this subpart, GMP's include, therefore, the system
whereby the manufacturer receives the specifications of the product
and/or process from the marketing authorization/product authorization
or license holder or applicant and ensures the product is made in
compliance with its specifications (qualified person certification in
the European Community (EC)).
     (d) Inspection means an onsite evaluation of a manufacturing
facility to determine whether such manufacturing facility is operating
in compliance with GMP's and/or commitments made as part of the
approval to market a product.
     (e) Inspection Report means the written observations and GMP's
compliance assessment completed by an authority listed in Appendix B of
this subpart.
     (f) Regulatory System means the body of legal requirements for
GMP's, inspections, and enforcements that ensure public health
protection and legal authority to assure adherence to these
requirements.

Sec. 26.2  Purpose.

    The provisions of this subpart govern the exchange between the
parties and normal endorsement by the receiving regulatory authority of
official good manufacturing practice (GMP) inspection reports after a
transitional period aimed at determination of the equivalence of the
regulatory systems of the parties, which is the cornerstone of this
subpart.

Sec. 26.3  Scope.

    (a) The provisions of this subpart shall apply to pharmaceutical
inspections carried out in the United States and Member States of the
European Community (EC) before products are marketed (hereafter
referred to as ``preapproval inspections'') as well as during their
marketing (hereafter referred to as ``postapproval inspections'').
    (b) Appendix A of this subpart names the laws, regulations, and
administrative provisions governing these inspections and the good
manufacturing practice (GMP) requirements.
    (c) Appendix B of this subpart lists the authorities participating
in activities under this subpart.
    (d) Sections 26.65, 26.66, 26.67, 26.68, 26.69, and 26.70 of
subpart C of this part do not apply to this subpart.

Sec. 26.4  Product coverage.

    (a) These provisions will apply to medicinal products for human or
animal use, intermediates and starting materials (as referred to in the
European Community (EC)) and to drugs for human or animal use,
biological products for human use, and active pharmaceutical
ingredients (as referred to in the United States), only to the extent
they are regulated by the authorities of both parties as listed in
Appendix B of this subpart.
    (b) Human blood, human plasma, human tissues and organs, and
veterinary immunologicals (under 9 CFR 101.2, ``veterinary
immunologicals'' are referred to as ``veterinary biologicals'') are
excluded from the scope of this subpart. Human plasma derivatives (such
as immunoglobulins and albumin), investigational medicinal products/new
drugs, human radiopharmaceuticals, and medicinal gases are also
excluded during the transition phase, their situation will be
reconsidered at the end of the transition period. Products regulated by
FDA's Center for Biologics Evaluation and Research as devices are not
covered under this subpart.
    (c) Appendix C of this subpart contains an indicative list of
products covered by this subpart.

Sec. 26.5  Length of transition period.

    A 3-year transition period will start immediately after the
effective date described in Sec. 26.80(a).

Sec. 26.6  Equivalence assessment.

    (a) The criteria to be used by the parties to assess equivalence
are listed in Appendix D of this subpart. Information pertaining to the
criteria under European Community (EC) competence will be provided by
the EC.
    (b) The authorities of the parties will establish and communicate
to each other their draft programs for assessing the equivalence of the
respective regulatory systems in terms of quality assurance of the
products and consumer protection. These programs will be carried out,
as deemed necessary by the regulatory authorities, for post- and
preapproval inspections and for various product classes or processes.
    (c) The equivalence assessment shall include information exchanges
(including inspection reports), joint training, and joint inspections
for the purpose of assessing regulatory systems and the authorities'
capabilities. In conducting the equivalence assessment, the parties
will ensure that efforts are made to save resources.
    (d) Equivalence assessment for authorities added to Appendix B of
this subpart after the effective date of this part as described in
Sec. 26.80(a) will be conducted as described in this subpart, as soon
as practicable.

[[Page 17750]]

Sec. 26.7  Participation in the equivalence assessment and
determination.

    The authorities listed in Appendix B of this subpart will actively
participate in these programs to build a sufficient body of evidence
for their equivalence determination. Both parties will exercise good
faith efforts to complete equivalence assessment as expeditiously as
possible to the extent the resources of the authorities allow.

Sec. 26.8  Other transition activities.

    As soon as possible, the authorities will jointly determine the
essential information which must be present in inspection reports and
will cooperate to develop mutually agreed inspection report format(s).

Sec. 26.9  Equivalence determination.

    (a) Equivalence is established by having in place regulatory
systems covering the criteria referred to in Appendix D of this
subpart, and a demonstrated pattern of consistent performance in
accordance with these criteria. A list of authorities determined as
equivalent shall be agreed to by the Joint Sectoral Committee at the
end of the transition period, with reference to any limitation in terms
of inspection type (e.g., postapproval or preapproval) or product
classes or processes.
    (b) The parties will document insufficient evidence of equivalence,
lack of opportunity to assess equivalence or a determination of
nonequivalence, in sufficient detail to allow the authority being
assessed to know how to attain equivalence.

Sec. 26.10   Regulatory authorities not listed as currently equivalent.

    Authorities not currently listed as equivalent, or not equivalent
for certain types of inspections, product classes or processes may
apply for reconsideration of their status once the necessary corrective
measures have been taken or additional experience is gained.

Sec. 26.11   Start of operational period.

    (a) The operational period shall start at the end of the transition
period and its provisions apply to inspection reports generated by
authorities listed as equivalent for the inspections performed in their
territory.
    (b) In addition, when an authority is not listed as equivalent
based on adequate experience gained during the transition period, FDA
will accept for normal endorsement (as provided in Sec. 26.12)
inspection reports generated as a result of inspections conducted
jointly by that authority on its territory and another authority listed
as equivalent, provided that the authority of the Member State in which
the inspection is performed can guarantee enforcement of the findings
of the inspection report and require that corrective measures be taken
when necessary. FDA has the option to participate in these inspections,
and based on experience gained during the transition period, the
parties will agree on procedures for exercising this option.
    (c) In the European Community (EC), the qualified person will be
relieved of responsibility for carrying the controls laid down in
Article 22 paragraph 1(b) of Council Directive 75/319/EEC (see Appendix
A of this subpart) provided that these controls have been carried out
in the United States and that each batch/lot is accompanied by a batch
certificate (in accordance with the World Health Organization
Certification Scheme on the Quality of Medicinal Products) issued by
the manufacturer certifying that the product complies with requirements
of the marketing authorization and signed by the person responsible for
releasing the batch/lot.

Sec. 26.12  Nature of recognition of inspection reports.

    (a) Inspection reports (containing information as established under
Sec. 26.8), including a good manufacturing practice (GMP) compliance
assessment, prepared by authorities listed as equivalent, will be
provided to the authority of the importing party. Based on the
determination of equivalence in light of the experience gained, these
inspection reports will normally be endorsed by the authority of the
importing party, except under specific and delineated circumstances.
Examples of such circumstances include indications of material
inconsistencies or inadequacies in an inspection report, quality
defects identified in the postmarket surveillance or other specific
evidence of serious concern in relation to product quality or consumer
safety. In such cases, the authority of the importing party may request
clarification from the authority of the exporting party which may lead
to a request for reinspection. The authorities will endeavor to respond
to requests for clarification in a timely manner.
    (b) Where divergence is not clarified in this process, an authority
of the importing country may carry out an inspection of the production
facility.

Sec. 26.13  Transmission of postapproval inspection reports.

    Postapproval good manufacturing practice (GMP) inspection reports
concerning products covered by this subpart will be transmitted to the
authority of the importing country within 60 calendar days of the
request. Should a new inspection be needed, the inspection report will
be transmitted within 90 calendar days of the request.

Sec. 26.14  Transmission of preapproval inspection reports.

    (a) A preliminary notification that an inspection may have to take
place will be made as soon as possible.
    (b) Within 15 calendar days, the relevant authority will
acknowledge receipt of the request and confirm its ability to carry out
the inspection. In the European Community (EC), requests will be sent
directly to the relevant authority, with a copy to the European Agency
for the Evaluation of Medicinal Products (EMEA). If the authority
receiving the request cannot carry out the inspection as requested, the
requesting authority shall have the right to conduct the inspection.
    (c) Reports of preapproval inspections will be sent within 45
calendar days of the request that transmitted the appropriate
information and detailed the precise issues to be addressed during the
inspection. A shorter time may be necessary in exceptional cases and
these will be described in the request.

Sec. 26.15   Monitoring continued equivalence.

    Monitoring activities for the purpose of maintaining equivalence
shall include review of the exchange of inspection reports and their
quality and timeliness; performance of a limited number of joint
inspections; and the conduct of common training sessions.

Sec. 26.16   Suspension.

    (a) Each party has the right to contest the equivalence of a
regulatory authority. This right will be exercised in an objective and
reasoned manner in writing to the other party.
    (b) The issue shall be discussed in the Joint Sectoral Committee
promptly upon such notification. Where the Joint Sectoral Committee
determines that verification of equivalence is required, it may be
carried out jointly by the parties in a timely manner, under Sec. 26.6.
    (c) Efforts will be made by the Joint Sectoral Committee to reach
unanimous consent on the appropriate action. If agreement to suspend is
reached in the Joint Sectoral Committee, an authority may be suspended
immediately thereafter. If no agreement is reached in the Joint
Sectoral Committee, the matter is referred to the Joint Committee as
described in Sec. 26.73. If no unanimous consent is reached within 30
days after such notification, the contested authority will be
suspended.
    (d) Upon the suspension of authority previously listed as
equivalent, a party

[[Page 17751]]

is no longer obligated to normally endorse the inspection reports of
the suspended authority. A party shall continue to normally endorse the
inspection reports of that authority prior to suspension, unless the
authority of the receiving party decides otherwise based on health or
safety considerations. The suspension will remain in effect until
unanimous consent has been reached by the parties on the future status
of that authority.

Sec. 26.17  Role and composition of the Joint Sectoral Committee.

    (a) A Joint Sectoral Committee is set up to monitor the activities
under both the transitional and operational phases of this subpart.
    (b) The Joint Sectoral Committee will be cochaired by a
representative of FDA for the United States and a representative of the
European Community (EC) who each will have one vote. Decisions will be
taken by unanimous consent.
    (c) The Joint Sectoral Committee's functions will include:
    (1) Making a joint assessment, which must be agreed by both
parties, of the equivalence of the respective authorities;
    (2) Developing and maintaining the list of equivalent authorities,
including any limitation in terms of inspecting type or products, and
communicating the list to all authorities and the Joint Committee;
    (3) Providing a forum to discuss issues relating to this subpart,
including concerns that an authority may be no longer equivalent and
opportunity to review product coverage; and
    (4) Consideration of the issue of suspension.
    (d) The Joint Sectoral Committee shall meet at the request of
either party and, unless the cochairs otherwise agree, at least once
each year. The Joint Committee will be kept informed of the agenda and
conclusions of meetings of the Joint Sectoral Committee.

Sec. 26.18   Regulatory collaboration.

    (a) The parties and authorities shall inform and consult one
another, as permitted by law, on proposals to introduce new controls or
to change existing technical regulations or inspection procedures and
to provide the opportunity to comment on such proposals.
    (b) The parties shall notify each other in writing of any changes
to Appendix B of this subpart.

Sec. 26.19   Information relating to quality aspects.

    The authorities will establish an appropriate means of exchanging
information on any confirmed problem reports, corrective actions,
recalls, rejected import consignments and other regulatory and
enforcement problems for products subject to this subpart.

Sec. 26.20  Alert system.

    (a) The details of an alert system will be developed during the
transitional period. The system will be maintained in place at all
times. Elements to be considered in developing such a system are
described in Appendix E of this subpart.
    (b) Contact points will be agreed between both parties to permit
authorities to be made aware with the appropriate speed in case of
quality defect, recalls, counterfeiting, and other problems concerning
quality, which could necessitate additional controls or suspension of
the distribution of the product.

Sec. 26.21  Safeguard clause.

    Each party recognizes that the importing country has a right to
fulfill its legal responsibilities by taking actions necessary to
ensure the protection of human and animal health at the level of
protection it deems appropriate. This includes the suspension of the
distribution, product detention at the border of the importing country,
withdrawal of the batches and any request for additional information or
inspection as provided in Sec. 26.12.

Appendix A of Subpart A--List of Applicable Laws, Regulations, and
Administrative Provisions

1. For the European Community:

    [Copies of EC documents may be obtained from the European
Document Research, 1100 17th St. NW., suite 301, Washington, DC
20036. EC documents may be viewed on the European Commission
Pharmaceuticals Units web site at ``http://dg3.eudra.org.'']
Council Directive 65/65/EEC of 26 January 1965 on the approximation
of provisions laid down by law, regulation, or administrative action
relating to proprietary medicinal products as extended, widened, and
amended.
Council Directive 75/319/EEC of 20 May 1975 on the approximation of
provisions laid down by law, regulation or administrative action
relating to proprietary medicinal products as extended, widened and
amended.
Council Directive 81/851/EEC of 6 November 1981 on the approximation
of the laws of the Member States relating to veterinary medicinal
products as widened and amended.
Commission Directive 91/356/EEC of 13 June 1991 laying down the
principles and guidelines of good manufacturing practice for
medicinal products for human use.
Commission Directive 91/412/EEC of 23 July 1991 laying down the
principles and guidelines of good manufacturing practice for
veterinary medicinal products.
Council Regulation No (EEC) 2309/93 of 23 July 1993 laying down
Community procedures for the authorization and supervision of
medicinal products for human and veterinary use and establishing a
European Agency for the Evaluation of Medicinal Products.
Council Directive 92/25/EEC of 31 March 1992 on the wholesale
distribution of medicinal products for human use & Guide to Good
Distribution Practice.
Current version of the Guide to Good Manufacturing Practice, Rules
Governing Medicinal Products in the European Community, Volume IV.

2. For the United States :

    [Copies of FDA documents may be obtained from the Government
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA
documents, except the FDA Compliance Program Guidance Manual, may be
viewed on FDA's Internet web site at ``http://www.FDA.gov''.]
Relevant sections of the United States Federal Food, Drug, and
Cosmetic Act and the United States Public Health Service Act.
Relevant sections of Title 21, United States Code of Federal
Regulations (CFR) Parts 1-99, Parts 200-299, Parts 500-599, and
Parts 600-799.
Relevant sections of the FDA Investigations Operations Manual, the
FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance
Manual, the FDA Compliance Program Guidance Manual, and other FDA
guidances.

Appendix B of Subpart A--List of Authorities

1. For the United States:

In the United States, the regulatory authority is the Food and Drug
Administration.

2. For the European Community:

In the European Community, the regulatory authorities are the
following :
 Austria: Bundesministerium Fur Arbeit, Gesundheit, und Soziales,
Wien.
Belgium: Ministerie van Sociale Zakem, Volksgezondheid en Leefmilieu
/Ministere des Affaires Sociales, Sante Publique et Environment/
Algemeine Farmaceutische Inspectie, Inspection Generale de la
Pharmacie, Bruxelles, Brussel.
Denmark: Laegemiddelstryelsen, (Danish Medicines Agency), Bronshoj.
Finland: Laakelaittos/Lakemedelsverket (National Agency for
Medicines), Helsinki.
France: Agence du Medicament, Direction de l'inspection et des
etablissements, Saint Denis. (Human). Agence Nationale du Medicament
Veterinaire, Fougeres (Veterinary).
Germany: Bundesgesundheitsministerium, Bonn. Paul-Ehrlich Institut,
Langen (biologicals only). Zustandige Behorden der 16 Bundeslander:
Bayern, Berlin Brandenberg, Bremen, Hamburg, Hessen, Niedersachsen,
Nordrhein-Westfalen, Rheinland-Pfalz, Mecklenberg-Vorpommern,
Saarland, Sachsen, Sachsenanhalt, Schleswog-Holstein, Thuringen.
Greece: Ministry of Health and Welfare, National Drug Organisation
(E.O.F.), Athens.
Ireland: Irish Medicines Board, Dublin.

[[Page 17752]]

Italy: Ministero della Sanita, Dipartimento Farmaci e
Farmacovigilanza, Roma. (Human). Ministero della Sanita,
Dipartimento alimenti e nutrizione e sanita pubblica veterinaria -
Div. IX, Roma (Veterinary).
Luxembourg: Direction de la Sante, Division de la Pharmacie et des
Medicaments, Luxembourg.
The Netherlands: Staatstoezicht op de Volksgezondheid, Inspectie
voor de Gezondheidszorg, Rijswijk.
Portugal: Instituto da Farmacia e do Medicamento (INFARMED), Lisboa.
Spain: Ministerio Sanidad y Consumo, Subdireccion. General de
Control Farmaceutico, Madrid. (Human) Ministerio de Agricultura
Pesca y Alimentacion, Madrid, (Veterinary).
Sweden: Lakemedelsverket (Medical Products Agency), Uppsala.
United Kingdom: Medicines Control Agency, London. Veterinary
Medicines Directorate, Addlestone.
European Union: European Commission, Brussels. European Agency for
the Evaluation of Medicinal Products (EMEA), London.

Appendix C of Subpart A--Indicative List of Products Covered by Subpart
A

Recognizing that precise definition of medicinal products and drugs
are to be found in the legislations referred to above, an indicative
list of products covered by this arrangement is given below:
    - human medicinal products including prescription and
nonprescription drugs;
    - human biologicals including vaccines, and immunologicals;
    - veterinary pharmaceuticals, including prescription and
nonprescription drugs, with the exclusion of veterinary
immunologicals (Under 9 CFR 101.2 ``veterinary immunologicals'' are
referred to as ``veterinary biologicals.'');
    - premixes for the preparation of veterinary medicated feeds
(EC), Type A medicated articles for the preparation of veterinary
medicated feeds (United States);
    - intermediate products and active pharmaceutical ingredients or
bulk pharmaceuticals (United States)/starting materials (EC).

Appendix D of Subpart A--Criteria for Assessing Equivalence for Post-
and Preapproval

I. Legal/Regulatory authority and structures and procedures providing
for post- and preapproval:

A. Appropriate statutory mandate and jurisdiction.
B. Ability to issue and update binding requirements on GMP's and
guidance documents.
C. Authority to make inspections, review and copy documents, and to
take samples and collect other evidence.
D. Ability to enforce requirements and to remove products found in
violation of such requirements from the market.
E. Substantive current good manufacturing requirements.
F. Accountability of the regulatory authority.
G. Inventory of current products and manufacturers.
H. System for maintaining or accessing inspection reports, samples
and other analytical data, and other firm/product information
relating to matters covered by subpart A of this part.

II. Mechanisms in place to assure appropriate professional standards
and avoidance of conflicts of interest.

III. Administration of the regulatory authority:

A. Standards of education/qualification and training.
B. Effective quality assurance systems measures to ensure adequate
job performance.
C. Appropriate staffing and resources to enforce laws and
regulations.

IV. Conduct of inspections:

A. Adequate preinspection preparation, including appropriate
expertise of investigator/team, review of firm/product and
databases, and availability of appropriate inspection equipment.
B. Adequate conduct of inspection, including statutory access to
facilities, effective response to refusals, depth and competence of
evaluation of operations, systems, and documentation; collection of
evidence; appropriate duration of inspection and completeness of
written report of observations to firm management.
C. Adequate postinspection activities, including completeness of
inspectors' report, inspection report review where appropriate, and
conduct of followup inspections and other activities where
appropriate, assurance of preservation and retrieval of records.

V. Execution of regulatory enforcement actions to achieve corrections,
designed to prevent future violations, and to remove products found in
violation of requirements from the market.

VI. Effective use of surveillance systems:

A. Sampling and analysis.
B. Recall monitoring.
C. Product defect reporting system.
D. Routine surveillance inspections.
E. Verification of approved manufacturing process changes to
marketing authorizations/approved applications.

VII. Additional specific criteria for preapproval inspections:

A. Satisfactory demonstration through a jointly developed and
administered training program and joint inspections to assess the
regulatory authorities' capabilities.
B. Preinspection preparation includes the review of appropriate
records, including site plans and drug master file or similar
documentation to enable adequate inspections.
C. Ability to verify chemistry, manufacturing, and control data
supporting an application is authentic and complete.
D. Ability to assess and evaluate research and development data as
scientifically sound, especially transfer technology of pilot, scale
up and full scale production batches.
E. Ability to verify conformity of the onsite processes and
procedures with those described in the application.
F. Review and evaluate equipment installation, operational and
performance qualification data, and evaluate test method validation.

Appendix E of Subpart A--Elements to be Considered in Developing a Two-
way Alert System

1. Documentation

- Definition of a crisis/emergency and under what circumstances an
alert is required
- Standard Operating Procedures (SOP's)
- Mechanism of health hazards evaluation and classification
- Language of communication and transmission of information

2. Crisis Management System

- Crisis analysis and communication mechanisms
- Establishment of contact points
- Reporting mechanisms

3. Enforcement Procedures

- Followup mechanisms
- Corrective action procedures

4. Quality Assurance System

- Pharmacovigilance programme
- Surveillance/monitoring of implementation of corrective action

5. Contact Points

For the purpose of subpart A of this part, the contact points for
the alert system will be:

A. For the European Community:

the Executive Director of the European Agency for the Evaluation of
Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London
E14 4HB, England. Telephone 44-171-418 8400, Fax 418 8416.

B. For the United States :

Division of Emergency and Investigational Operations (DEIO), Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Telephone 301-443-1240, Fax 301-443-3757.

 Subpart B--Specific Sector Provisions for Medical Devices

Sec. 26.31  Purpose.

    (a) The purpose of this subpart is to specify the conditions under
which a party will accept the results of quality system-related
evaluations and inspections and premarket evaluations of the other
party with regard to medical devices as conducted by listed conformity
assessment bodies (CAB's) and to provide for other related cooperative
activities.
    (b) This subpart is intended to evolve as programs and policies of
the parties evolve. The parties will review this subpart periodically,
in order to assess progress and identify potential enhancements to this
subpart as FDA and European Community (EC) policies evolve over time.

Sec. 26.32  Scope.

    (a) The provisions of this subpart shall apply to the exchange and,
where appropriate, endorsement of the following types of reports from
conformity assessment bodies (CAB's) assessed to be equivalent:

[[Page 17753]]

    (1) Under the U.S. system, surveillance/postmarket and initial/
preapproval inspection reports;
    (2) Under the U.S. system, premarket (510(k)) product evaluation
reports;
    (3) Under the European Community (EC) system, quality system
evaluation reports; and
    (4) Under the EC system, EC type examination and verification
reports.
    (b) Appendix A of this subpart names the legislation, regulations,
and related procedures under which:
    (1) Products are regulated as medical devices by each party;
    (2) CAB's are designated and confirmed; and
    (3) These reports are prepared.
    (c) For purposes of this subpart, equivalence means that: CAB's in
the EC are capable of conducting product and quality systems
evaluations against U.S. regulatory requirements in a manner equivalent
to those conducted by FDA; and CAB's in the United States are capable
of conducting product and quality systems evaluations against EC
regulatory requirements in a manner equivalent to those conducted by EC
CAB's.

Sec. 26.33  Product coverage.

    (a) There are three components to this subpart each covering a
discrete range of products:
    (1) Quality System Evaluations. U.S.-type surveillance/postmarket
and initial/preapproval inspection reports and European Community (EC)-
type quality system evaluation reports will be exchanged with regard to
all products regulated under both U.S. and EC law as medical devices.
    (2) Product Evaluation. U.S.-type premarket (510(k)) product
evaluation reports and EC-type-testing reports will be exchanged only
with regard to those products classified under the U.S. system as Class
I/Class II-Tier 2 medical devices which are listed in Appendix B of
this subpart.
    (3) Postmarket Vigilance Reports. Postmarket vigilance reports will
be exchanged with regard to all products regulated under both U.S. and
EC law as medical devices.
    (b) Additional products and procedures may be made subject to this
subpart by agreement of the parties.

Sec. 26.34  Regulatory authorities.

    The regulatory authorities shall have the responsibility of
implementing the provisions of this subpart, including the designation
and monitoring of conformity assessment bodies (CAB's). Regulatory
authorities will be specified in Appendix C of this subpart.. Each
party will promptly notify the other party in writing of any change in
the regulatory authority for a country.

Sec. 26.35  Length and purpose of transition period.

    There will be a 3-year transition period immediately following the
date described in Sec. 26.80(a). During the transition period, the
parties will engage in confidence-building activities for the purpose
of obtaining sufficient evidence to make determinations concerning the
equivalence of conformity assessment bodies (CAB's) of the other party
with respect to the ability to perform quality system and product
evaluations or other reviews resulting in reports to be exchanged under
this subpart.

Sec. 26.36  Listing of CAB's.

    Each party shall designate conformity assessment bodies (CAB's) to
participate in confidence-building activities by transmitting to the
other party a list of CAB's which meet the criteria for technical
competence and independence, as identified in Appendix A of this
subpart. The list shall be accompanied by supporting evidence.
Designated CAB's will be listed in Appendix D of this subpart for
participation in the confidence building activities once confirmed by
the importing party. Nonconfirmation would have to be justified based
on documented evidence.

Sec. 26.37  Confidence building activities.

    (a) At the beginning of the transitional period, the Joint Sectoral
Group will establish a joint confidence building program calculated to
provide sufficient evidence of the capabilities of the designated
conformity assessment bodies (CAB's) to perform quality system or
product evaluations to the specifications of the parties.
    (b) The joint confidence building program should include the
following actions and activities:
    (1) Seminars designed to inform the parties and CAB's about each
party's regulatory system, procedures, and requirements;
    (2) Workshops designed to provide the parties with information
regarding requirements and procedures for the designation and
surveillance of CAB's;
    (3) Exchange of information about reports prepared during the
transition period;
    (4) Joint training exercises; and
    (5) Observed inspections.
    (c) During the transition period, any significant problem that is
identified with a CAB may be the subject of cooperative activities, as
resources allow and as agreed to by the regulatory authorities, aimed
at resolving the problem.
    (d) Both parties will exercise good faith efforts to complete the
confidence building activities as expeditiously as possible to the
extent that the resources of the parties allow.
    (e) Both the parties will each prepare annual progress reports
which will describe the confidence building activities undertaken
during each year of the transition period. The form and content of the
reports will be determined by the parties through the Joint Sectoral
Committee.

Sec. 26.38  Other transition period activities.

    (a) During the transition period, the parties will jointly
determine the necessary information which must be present in quality
system and product evaluation reports.
    (b) The parties will jointly develop a notification and alert
system to be used in case of defects, recalls, and other problems
concerning product quality that could necessitate additional actions
(e.g., inspections by the parties of the importing country) or
suspension of the distribution of the product.

Sec. 26.39  Equivalence assessment.

    (a) In the final 6 months of the transition period, the parties
shall proceed to a joint assessment of the equivalence of the
conformity assessment bodies (CAB's) that participated in the
confidence building activities. CAB's will be determined to be
equivalent provided they have demonstrated proficiency through the
submission of a sufficient number of adequate reports. CAB's may be
determined to be equivalent with regard to the ability to perform any
type of quality system or product evaluation covered by this subpart
and with regard to any type of product covered by this subpart. The
parties shall develop a list contained in Appendix E of this subpart of
CAB's determined to be equivalent which shall contain a full
explanation of the scope of the equivalency determination, including
any appropriate limitations, with regard to performing any type of
quality system or product evaluation.
    (b) The parties shall allow CAB's not listed for participation in
this subpart, or listed for participation only as to certain types of
evaluations, to apply for participation in this subpart once the
necessary measures have been taken or sufficient experience has been
gained, in accordance with Sec. 26.46.
    (c) Decisions concerning the equivalence of CAB's must be agreed to
by both parties.

[[Page 17754]]

Sec. 26.40  Start of the operational period.

    (a) The operational period will start at the end of the transition
period after the parties have developed the list of conformity
assessment bodies (CAB's) found to be equivalent. The provisions of
Secs. 26.40, 26.41, 26.42, 26.43, 26.44, 26.45, and 26.46 will apply
only with regard to listed CAB's and only to the extent of any
specifications and limitations contained on the list with regard to a
CAB.
    (b) The operational period will apply to quality system evaluation
reports and product evaluation reports generated by CAB's listed in
accordance with this subpart for the evaluations performed in the
respective territories of the parties, except if the parties agree
otherwise.

Sec. 26.41  Exchange and endorsement of quality system evaluation
reports.

    (a) Listed European Community (EC) conformity assessment bodies
(CAB's) will provide FDA with reports of quality system evaluations, as
follows:
    (1) For preapproval quality system evaluations, EC CAB's will
provide full reports; and
    (2) For surveillance quality system evaluations, EC CAB's will
provide abbreviated reports.
    (b) Listed U.S. CAB's will provide to the EC Notified Body of the
manufacturer's choice:
    (1) Full reports of initial quality system evaluations;
    (2) Abbreviated reports of quality systems surveillance audits.
    (c) If the abbreviated reports do not provide sufficient
information, the importing party may request additional clarification
from the CAB.
    (d) Based on the determination of equivalence in light of the
experience gained, the quality system evaluation reports prepared by
the CAB's listed as equivalent will normally be endorsed by the
importing party, except under specific and delineated circumstances.
Examples of such circumstances include indications of material
inconsistencies or inadequacies in a report, quality defects identified
in postmarket surveillance or other specific evidence of serious
concern in relation to product quality or consumer safety. In such
cases, the importing party may request clarification from the exporting
party which may lead to a request for reinspection. The parties will
endeavor to respond to requests for clarification in a timely manner.
Where divergence is not clarified in this process, the importing party
may carry out the quality system evaluation.

Sec. 26.42  Exchange and endorsement of product evaluation reports.

    (a) European Community (EC) conformity assessment bodies (CAB's)
listed for this purpose will, subject to the specifications and
limitations on the list, provide to FDA 510(k) premarket notification
assessment reports prepared to U.S. medical device requirements.
    (b) U.S. CAB's will, subject to the specifications and limitations
on the list, provide to the EC Notified Body of the manufacturer's
choice, type examination, and verification reports prepared to EC
medical device requirements.
    (c) Based on the determination of equivalence in light of the
experience gained, the product evaluation reports prepared by the CAB's
listed as equivalent will normally be endorsed by the importing party,
except under specific and delineated circumstances. Examples of such
circumstances include indications of material inconsistencies,
inadequacies, or incompleteness in a product evaluation report, or
other specific evidence of serious concern in relation to product
safety, performance, or quality. In such cases, the importing party may
request clarification from the exporting party which may lead to a
request for a reevaluation. The parties will endeavor to respond to
requests for clarification in a timely manner. Endorsement remains the
responsibility of the importing party.

Sec. 26.43  Transmission of quality system evaluation reports.

    Quality system evaluation reports covered by Sec. 26.41 concerning
products covered by this subpart shall be transmitted to the importing
party within 60 calendar days of a request by the importing party.
Should a new inspection be requested, the time period shall be extended
by an additional 30 calendar days. A party may request a new
inspection, for cause, identified to the other party. If the exporting
party cannot perform an inspection within a specified period of time,
the importing party may perform an inspection on its own.

Sec. 26.44  Transmission of product evaluation reports.

    Transmission of product evaluation reports will take place
according to the importing party's specified procedures.

Sec. 26.45  Monitoring continued equivalence.

    Monitoring activities will be carried out in accordance with
Sec. 26.69.

Sec. 26.46  Listing of additional CAB's.

    (a) During the operational phase, additional conformity assessment
bodies (CAB's) will be considered for equivalence using the procedures
and criteria described in Secs. 26.36, 26.37, and 26.39, taking into
account the level of confidence gained in the overall regulatory system
of the other party.
    (b) Once a designating authority considers that such CAB's, having
undergone the procedures of Secs. 26.36, 26.37, and 26.39, may be
determined to be equivalent, it will then designate those bodies on an
annual basis. Such procedures satisfy the procedures of Sec. 26.66(a)
and (b).
    (c) Following such annual designations, the procedures for
confirmation of CAB's under Sec. 26.66(c) and (d) shall apply.

Sec. 26.47  Role and composition of the Joint Sectoral Committee.

    (a) The Joint Sectoral Committee for this subpart is set up to
monitor the activities under both the transitional and operational
phases of this subpart.
    (b) The Joint Sectoral Committee will be cochaired by a
representative of the Food and Drug Administration (FDA) for the United
States and a representative of the European Community (EC) who will
each have one vote. Decisions will be taken by unanimous consent.
    (c) The Joint Sectoral Committee's functions will include:
    (1) Making a joint assessment of the equivalence of conformity
assessment bodies (CAB's);
    (2) Developing and maintaining the list of equivalent CAB's,
including any limitation in terms of their scope of activities and
communicating the list to all authorities and the Joint Committee
described in subpart C of this part;
    (3) Providing a forum to discuss issues relating to this subpart,
including concerns that a CAB may no longer be equivalent and
opportunity to review product coverage; and
    (4) Consideration of the issue of suspension.

Sec. 26.48   Harmonization.

    During both the transitional and operational phases of this
subpart, both parties intend to continue to participate in the
activities of the Global Harmonization Task Force and utilize the
results of those activities to the extent possible. Such participation
involves developing and reviewing documents developed by the Global
Harmonization Task Force and jointly determining whether they are
applicable to the implementation of this subpart.

Sec. 26.49  Regulatory cooperation.

    (a) The parties and authorities shall inform and consult with one
another, as permitted by law, of proposals to

[[Page 17755]]

introduce new controls or to change existing technical regulations or
inspection procedures and to provide the opportunity to comment on such
proposals.
    (b) The parties shall notify each other in writing of any changes
to Appendix A of this subpart.

Sec. 26.50  Alert system and exchange of postmarket vigilance reports.

    (a) An alert system will be set up during the transition period and
maintained thereafter by which the parties will notify each other when
there is an immediate danger to public health. Elements of such a
system will be described in an Appendix F of this subpart. As part of
that system, each party shall notify the other party of any confirmed
problem reports, corrective actions, or recalls. These reports are
regarded as part of ongoing investigations.
    (b) Contact points will be agreed between both parties to permit
authorities to be made aware with the appropriate speed in case of
quality defect, batch recalls, counterfeiting and other problems
concerning quality, which could necessitate additional controls or
suspension of the distribution of the product.

Appendix A of Subpart B--Relevant Legislation, Regulations and
Procedures

1. For the European Community (EC) the following legislation applies to
Sec. 26.42(a) of this subpart:

    [Copies of EC documents may be obtained from the European
Document Research, 1100 17th St. NW., suite 301, Washington, DC
20036.]
a. Council Directive 90/385/EEC of 20 June 1990 on active
implantable medical devices
    OJ No. L 189, 20.7. 1990, p. 17. Conformity assessment
procedures.
    Annex 2 (with the exception of section 4)
    Annex 4
    Annex 5
b. Council Directive 93/42/EEC of 14 June 1993 on Medical Devices OJ
No. L 169,12.7.1993, p.1. Conformity assessment procedures.
    Annex 2 (with the exception of section 4)
    Annex 3
    Annex 4
    Annex 5
    Annex 6

2. For the United States, the following legislation applies to
Sec. 26.32(a):

    [Copies of FDA documents may be obtained from the Government
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents
may be viewed on FDA's Internet web site at ``http://www.fda.gov''.]
a. The Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 et seq.
b. The Public Health Service Act, 42 U.S.C. 201 et seq.
c. Regulations of the United States Food and Drug Administration
found at 21 CFR, in particular, Parts 800 to 1299.
d. Medical Devices; Third Party Review of Selected Premarket
Notifications; Pilot Program, 61 FR 14789-14796 (April 3, 1996).

Appendix B of Subpart B--Scope of Product Coverage

1. Initial Coverage of the Transition Period

Upon entry into force of this subpart as described in Sec. 26.80 (it
is understood that the date of entry into force will not occur prior
to June 1, 1998, unless the parties decide otherwise), products
qualifying for the transitional arrangements under this subpart
include:
    a. All Class I products requiring premarket evaluations in the
United States--see Table 1.
    b. Those Class II products listed in Table 2.

2. During the Transition Period

The parties will jointly identify additional product groups,
including their related accessories, in line with their respective
priorities as follows:
    a. Those for which review may be based primarily on written
guidance which the parties will use their best efforts to prepare
expeditiously; and
    b. Those for which review may be based primarily on
international standards, in order for the parties to gain the
requisite experience.
The corresponding additional product lists will be phased in on an
annual basis. The parties may consult with industry and other
interested parties in determining which products will be added.

3. Commencement of the Operational Period

    a. At the commencement of the operational period, product
coverage shall extend to all Class I/II products covered during the
transition period.
    b. FDA will expand the program to categories of Class II devices
as is consistent with the results of the pilot, and with FDA's
ability to write guidance documents if the device pilot for the
third party review of medical devices is successful. The MRA will
cover to the maximum extent feasible all Class II devices listed in
Table 3 for which FDA-accredited third party review is available in
the United States.

4. Unless explicitly included by joint decision of the parties, this
part does not cover any U.S. Class II-tier 3 or any Class III product
under either system.

    [FDA is codifying the lists of medical devices contained in the
following tables as they appear in the medical device annex of the
``Agreement on Mutual Recognition Between the United States of
America and the European Community.'' As a result of the Food and
Drug Administration Modernization Act of 1997, however, the medical
devices included in these tables will change.]

Table 1.--Class I Products Requiring Premarket Evaluations in the United
States, Included in Scope of Product Coverage at Beginning of Transition
                                Period\1\
------------------------------------------------------------------------
          21 CFR Section No.                    Regulation Name
------------------------------------------------------------------------
                                           Product Code--Device Name
------------------------------------------------------------------------
Anesthesiology Panel (21 CFR Part
 868)
    868.1910                           Esophageal Stethoscope
                                       BZW--Stethoscope, Esophageal
    868.5620                           Breathing Mouthpiece
                                       BYP--Mouthpiece, Breathing
    868.5640                           Medicinal Nonventilatory
                                        Nebulizer (Atomizer)
                                       CCQ--Nebulizer, Medicinal,
                                        Nonventilatory (Atomizer)
    868.5675                           Rebreathing Device
                                       BYW--Device, Rebreathing
    868.5700                           Nonpowered Oxygen Tent
                                       FOG--Hood, Oxygen, Infant
                                       BYL--Tent, Oxygen
    868.6810                           Tracheobronchial Suction Catheter
                                       BSY--Catheters, Suction,
                                        Tracheobronchial

[[Page 17756]]


Cardiovascular Panel
    (None)
Dental Panel (21 CFR Part 872)
    872.3400                           Karaya and Sodium Borate With or
                                        Without Acacia Denture Adhesive
                                       KOM--Adhesive, Denture, Acacia
                                        and Karaya With Sodium Borate
    872.3700                           Dental Mercury (U.S.P.)
                                       ELY--Mercury
    872.4200                           Dental Handpiece and Accessories
                                       EBW--Controller, Food, Handpiece
                                        and Cord
                                       EFB--Handpiece, Air-Powered,
                                        Dental
                                       EFA--Handpiece, Belt and/or Gear
                                        Driven, Dental
                                       EGS--Handpiece, Contra- and Right-
                                        Angle Attachment, Dental
                                       EKX--Handpiece, Direct Drive, AC-
                                        Powered
                                       EKY--Handpiece, Water-Powered
    872.6640                           Dental Operative Unit and
                                        Accessories
                                       EIA--Unit, Operative Dental
Ear, Nose, and Throat Panel (21 CFR
 Part 874)
    874.1070                           Short Increment Sensitivity Index
                                        (SISI) Adapter
                                       ETR--Adapter, Short Increment
                                        Sensitivity Index (SISI)
    874.1500                           Gustometer
                                       ETM--Gustometer
    874.1800                           Air or Water Caloric Stimulator
                                       KHH--Stimulator, Caloric-Air
                                       ETP--Stimulator, Caloric-Water
    874.1925                           Toynbee Diagnostic Tube
                                       ETK--Tube, Toynbee Diagnostic
    874.3300                           Hearing Aid
                                       LRB--Face Plate Hearing-Aid
                                       ESD--Hearing-aid, Air-Conduction
    874.4100                           Epistaxis Balloon
                                       EMX--Balloon, Epistaxis
    874.5300                           ENT Examination and Treatment
                                        Unit
                                       ETF--Unit, Examining/Treatment,
                                        ENT
    874.5550                           Powered Nasal Irrigator
                                       KMA--Irrigator, Powered Nasal
    874.5840                           Antistammering Device
                                       KTH--Device, Anti-Stammering
Gastroenterology--Urology Panel (21
 CFR Part 876)
    876.5160                           Urological Clamp for Males
                                       FHA--Clamp, Penile
    876.5210                           Enema Kit
                                       FCE--Kit, Enema, (for Cleaning
                                        Purpose)
    876.5250                           Urine Collector and Accessories
                                       FAQ--Bag, Urine Collection, Leg,
                                        for External Use
General Hospital Panel (21 CFR Part
 880)
    880.5270                           Neonatal Eye Pad
                                       FOK--Pad, Neonatal Eye
    880.5420                           Pressure Infusor for an I.V. Bag
                                       KZD--Infusor, Pressure, for I.V.
                                        Bags
    880.5680                           Pediatric Position Holder
                                       FRP--Holder, Infant Position
    880.6250                           Patient Examination Glove
                                       LZB--Finger Cot
                                       FMC--Glove, Patient Examination
                                       LYY--Glove, Patient Examination,
                                        Latex
                                       LZA--Glove, Patient Examination,
                                        Poly
                                       LZC--Glove, Patient Examination,
                                        Speciality
                                       LYZ--Glove, Patient Examination,
                                        Vinyl
    880.6375                           Patient Lubricant
                                       KMJ--Lubricant, Patient
    880.6760                           Protective Restraint
                                       BRT--Restraint, Patient,
                                        Conductive
                                       FMQ--Restraint, Protective
Neurology Panel (21 CFR Part 882)
    882.1030                           Ataxiagraph
                                       GWW--Ataxiagraph
    882.1420                           Electroencephalogram (EEG) Signal
                                        Spectrum Analyzer
                                       GWS--Analyzer, Spectrum,
                                        Electroencephalogram Signal

[[Page 17757]]


    882.4060                           Ventricular Cannula
                                       HCD--Cannula, Ventricular
    882.4545                           Shunt System Implantation
                                        Instrument
                                       GYK--Instrument, Shunt System
                                        Implantation
    882.4650                           Neurosurgical Suture Needle
                                       HAS--Needle, Neurosurgical Suture
    882.4750                           Skull Punch
                                       GXJ--Punch, Skull
Obstetrics and Gynecology Panel
    (None)
Ophthalmology Panel (21 CFR Part 886)
    886.1780                           Retinoscope
                                       HKM--Retinoscope, Battery-Powered
    886.1940                           Tonometer Sterilizer
                                       HKZ--Sterilizer, Tonometer
    886.4070                           Powered Corneal Burr
                                       HQS--Burr, Corneal, AC-Powered
                                       HOG--Burr, Corneal, Battery-
                                        Powered
                                       HRG--Engine, Trephine,
                                        Accessories, AC-Powered
                                       HFR--Engine, Trephine,
                                        Accessories, Battery-Powered
                                       HLD--Engine, Trephine,
                                        Accessories, Gas-Powered
    886.4370                           Keratome
                                       HNO--Keratome, AC-Powered
                                       HMY--Keratome, Battery-Powered
    886.5850                           Sunglasses (Nonprescription)
                                       HQY--Sunglasses (Nonprescription
                                        Including Photosensitive)
Orthopedic Panel (21 CFR Part 888)
    888.1500                           Goniometer
                                       KQX--Goniometer, AC-Powered
    888.4150                           Calipers for Clinical Use
                                       KTZ--Caliper
Physical Medicine Panel (21 CFR Part
 890)
    890.3850                           Mechanical Wheelchair
                                       LBE--Stroller, Adaptive
                                       IOR--Wheelchair, Mechanical
    890.5180                           Manual Patient Rotation Bed
                                       INY--Bed, Patient Rotation,
                                        Manual
    890.5710                           Hot or Cold Disposable Pack
                                       IMD--Pack, Hot or Cold,
                                        Disposable
Radiology Panel (21 CFR Part 892)
    892.1100                           Scintillation (Gamma) Camera
                                       IYX--Camera, Scintillation
                                        (Gamma)
    892.1110                           Positron Camera
                                       IZC--Camera, Positron
    892.1300                           Nuclear Rectilinear Scanner
                                       IYW--Scanner, Rectilinear,
                                        Nuclear
    892.1320                           Nuclear Uptake Probe
                                       IZD--Probe, Uptake, Nuclear
    892.1330                           Nuclear Whole Body Scanner
                                       JAM--Scanner, Whole Body, Nuclear
    892.1410                           Nuclear Electrocardiograph
                                        Synchronizer
                                       IVY--Synchronizer,
                                        Electrocardiograph, Nuclear
    892.1890                           Radiographic Film Illuminator
                                       IXC--Illuminator, Radiographic-
                                        Film
                                        JAG--Illuminator, Radiographic-
                                        Film, Explosion-Proof
    892.1910                           Radiographic Grid
                                       IXJ--Grid, Radiographic
    892.1960                           Radiographic Intensifying Screen
                                       WAM--Screen, Intensifying,
                                        Radiographic
    892.1970                           Radiographic ECG/Respirator
                                        Synchronizer
                                       IXO--Synchronizer, ECG/
                                        Respirator, Radiographic
    892.5650                           Manual Radionuclide Applicator
                                        System
                                       IWG--System, Applicator,
                                        Radionuclide, Manual
General and Plastic Surgery Panel (21
 CFR Part 878)
     878.4200                          Introduction/Drainage Catheter
                                        and Accessories
                                       KGZ--Accessories, Catheter
                                       GCE--Adaptor, Catheter
                                       FGY--Cannula, Injection
                                       GBA--Catheter, Balloon Type

[[Page 17758]]


                                       GBZ--Catheter, Cholangiography
                                       GBQ--Catheter, Continuous
                                        Irrigation
                                       GBY--Catheter, Eustachian,
                                        General & Plastic Surgery
                                       JCY--Catheter, Infusion
                                       GBX--Catheter, Irrigation
                                       GBP--Catheter, Multiple Lumen
                                       GBO--Catheter, Nephrostomy,
                                        General & Plastic Surgery
                                       GBN--Catheter, Pediatric, General
                                        & Plastic Surgery
                                       GBW--Catheter, Peritoneal
                                       GBS--Catheter, Ventricular,
                                        General & Plastic Surgery
                                       GCD--Connector, Catheter
                                       GCC--Dilator, Catheter
                                       GCB--Needle, Catheter
    878.4320                           Removable Skin Clip
                                       FZQ--Clip, Removable (Skin)
    878.4460                           Surgeon's Gloves
                                       KGO--Surgeon's Gloves
    878.4680                           Nonpowered, Single Patient,
                                        Portable Suction Apparatus
                                       GCY--Apparatus, Suction, Single
                                        Patient Use, Portable,
                                        Nonpowered
    878.4760                           Removable Skin Staple
                                       GDT--Staple, Removable (Skin)
    878.4820                           AC-Powered, Battery-Powered, and
                                        Pneumatically Powered Surgical
                                        Instrument Motors and
                                        Accessories/Attachments
                                       GFG--Bit, Surgical
                                       GFA--Blade, Saw, General &
                                        Plastic Surgery
                                       DWH--Blade, Saw, Surgical,
                                        Cardiovascular
                                       BRZ--Board, Arm (With Cover)
                                       GFE--Brush, Dermabrasion
                                       GFF--Bur, Surgical, General &
                                        Plastic Surgery
                                       KDG--Chisel (Osteotome)
                                       GFD--Dermatome
                                       GFC--Driver, Surgical, Pin
                                       GFB--Head, Surgical, Hammer
                                       GEY--Motor, Surgical Instrument,
                                        AC-Powered
                                       GET--Motor, Surgical Instrument,
                                        Pneumatic Powered
                                       DWI--Saw, Electrically Powered
                                       KFK--Saw, Pneumatically Powered
                                       HAB--Saw, Powered, and
                                        Accessories
    878.4960                           Air or AC-Powered Operating Table
                                        and Air or AC-Powered Operating
                                        Chair & Accessories
                                       GBB--Chair, Surgical, AC-Powered
                                       FQO--Table, Operating-Room, AC-
                                        Powered
                                       GDC--Table, Operating-Room,
                                        Electrical
                                        FWW--Table, Operating-Room,
                                        Pneumatic
                                       JEA--Table, Surgical with
                                        Orthopedic Accessories, AC-
                                        Powered
    880.5090                           Liquid Bandage
                                       KMF--Bandage, Liquid
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other
  medical device identifiers may be viewed on FDA's Internet Web Site at
  ``http://www.fda.gov/cdrh/prodcode.html''.

Table 2.--Class II Medical Devices Included in Scope of Product Coverage
  at Beginning of Transition Period (United States to develop guidance
 documents identifying U.S. requirements and European Community (EC) to
          identify standards needed to meet EC requirements)\1\
------------------------------------------------------------------------
     Panel        21 CFR Section              Regulation Name
----------------        No.       --------------------------------------
                ------------------
                                         Product Code--Device Name
------------------------------------------------------------------------
    RA           892.1000          Magnetic Resonance Diagnostic Device
                                   MOS--COIL, Magnetic Resonance,
                                    Specialty
                                   LNH--System, Nuclear Magnetic
                                    Resonance Imaging
                                   LNI--System, Nuclear Magnetic
                                    Resonance Spectroscopic
Diagnostic
 Ultrasound:
    RA           892.1540          Nonfetal Ultrasonic Monitor
                                   JAF--Monitor, Ultrasonic, Nonfetal
    RA           892.1550          Ultrasonic Pulsed Doppler Imaging
                                    System
                                   IYN--System, Imaging, Pulsed Doppler,
                                    Ultrasonic

[[Page 17759]]


    RA           892.1560          Ultrasonic Pulsed Echo Imaging System
                 ................  IYO--System, Imaging, Pulsed Echo,
                                    Ultrasonic
    RA           892.1570          Diagnostic Ultrasonic Transducer
                 ................  ITX--Transducer, Ultrasonic,
                                    Diagnostic
Diagnostic X-
 Ray Imaging
 Devices
 (except
 mammographic x-
 ray systems):
    RA           892.1600          Angiographic X-Ray System
                                   IZI--System, X-Ray, Angiographic
    RA           892.1650          Image-Intensified Fluoroscopic X-Ray
                                    System
                                   MQB--Solid State X-Ray Imager (Flat
                                    Panel/Digital Imager)
                                   JAA--System, X-Ray, Fluoroscopic,
                                    Image-Intensified
    RA           892.1680          Stationary X-Ray System
                                   KPR--System, X-Ray, Stationary
    RA           892.1720          Mobile X-Ray System
                                   IZL--System, X-Ray, Mobile
    RA           892.1740          Tomographic X-Ray System
                                   IZF--System, X-Ray, Tomographic
    RA           892.1750          Computed Tomography X-Ray System
                                   JAK--System, X-Ray, Tomography,
                                    Computed
ECG-Related
 Devices:
    CV           870.2340          Electrocardiograph
                 ................  DPS--Electrocardiograph
                 ................  MLC--Monitor, ST Segment
    CV           870.2350          Electrocardiograph Lead Switching
                                    Adaptor
                                   DRW--Adaptor, Lead Switching,
                                    Electrocardiograph
    CV           870.2360          Electrocardiograph Electrode
                                   DRX--Electrode, Electrocardiograph
    CV           870.2370          Electrocardiograph Surface Electrode
                                    Tester
                                   KRC--Tester, Electrode, Surface,
                                    Electrocardiographic
    NE           882.1400          Electroencephalograph
                                   GWQ--Electroencephalograph
    HO           880.5725          Infusion Pump (external only)
                                   MRZ--Accessories, Pump, Infusion
                                   FRN--Pump, Infusion
                                   LZF--Pump, Infusion, Analytical
                                    Sampling
                                   MEB--Pump, Infusion, Elastomeric
                                   LZH--Pump, Infusion, Enteral
                                   MHD--Pump, Infusion, Gallstone
                                    Dissolution
                                   LZG--Pump, Infusion, Insulin
                                   MEA--Pump, Infusion, PCA
Ophthalmic
 Instruments:
    OP            886.1570         Ophthalmoscope
                                   HLI--Ophthalmoscope, AC-Powered
                                   HLJ--Ophthalmoscope, Battery-Powered
    OP           886.1780          Retinoscope
                                   HKL--Retinoscope, AC-Powered
    OP           886.1850          AC-Powered Slit-Lamp Biomicroscope
                                   HJO--Biomicroscope, Slit-Lamp, AC-
                                    Powered
    OP           886.4150          Vitreous Aspiration and Cutting
                                    Instrument
                                   MMC--Dilator, Expansive Iris
                                    (Accessory)
                                   HQE--Instrument, Vitreous Aspiration
                                    and Cutting, AC-Powered
                                   HKP--Instrument, Vitreous Aspiration
                                    and Cutting, Battery-Powered
                                   MLZ--Vitrectomy, Instrument Cutter
    OP           886.4670          Phacofragmentation System
                                   HQC--Unit, Phacofragmentation
    SU           878.4580          Surgical Lamp
                                   HBI--Illuminator, Fiberoptic,
                                    Surgical Field
                                   FTF--Illuminator, Nonremote
                                   FTG--Illuminator, Remote
                                   HJE--Lamp, Fluorescein, AC-Powered
                                   FQP--Lamp, Operating-Room
                                   FTD--Lamp, Surgical
                                   GBC--Lamp, Surgical, Incandescent
                                   FTA--Light, Surgical, Accessories
                                   FSZ--Light, Surgical, Carrier
                                   FSY--Light, Surgical, Ceiling Mounted

[[Page 17760]]


                                   FSX--Light, Surgical, Connector
                                   FSW--Light, Surgical, Endoscopic
                                   FST--Light, Surgical, Fiberoptic
                                   FSS--Light, Surgical, Floor Standing
                                   FSQ--Light, Surgical, Instrument
    NE           882.5890          Transcutaneous Electrical Nerve
                                    Stimulator for Pain Relief
                                   GZJ--Stimulator, Nerve,
                                    Transcutaneous, For Pain Relief
                                   Noninvasive Blood Pressure
                                    Measurement Devices:
    CV           870.1120          Blood Pressure Cuff
                                   DXQ--Cuff, Blood-Pressure
    CV           870.1130          Noninvasive Blood Pressure
                                    Measurement System (except
                                    nonoscillometric)
                                   DXN--System, Measurement, Blood-
                                    Pressure, Noninvasive
    HO           880.6880          Steam Sterilizer (greater than 2
                                    cubic feet)
                                   FLE--Sterilizer, Steam
Clinical
 Thermometers:
    HO           880.2910          Clinical Electronic Thermometer
                                    (except tympanic or pacifier)
                                   FLL--Thermometer, Electronic,
                                    Clinical
    AN           868.5630          Nebulizer
                                   CAF--Nebulizer (Direct Patient
                                    Interface)
    AN           868.5925          Powered Emergency Ventilator
Hypodermic
 Needles and
 Syringes
 (except
 antistick and
 self-
 destruct):
    HO           880.5570          Hypodermic Single Lumen Needle
                                   MMK--Container, Sharpes
                                   FMI--Needle, Hypodermic, Single Lumen
                                   MHC--Port, Intraosseous, Implanted
    HO           880.5860          Piston Syringe
                                   FMF--Syringe, Piston
    OR           888.3020          Intramedullary Fixation Rod
                                   HSB--ROD, Fixation, Intramedullary
                                    and Accessories
External
 Fixators
 (except
 devices with
 no external
 components):
    OR           888.3030          Single/Multiple Component Metallic
                                    Bone Fixation Appliances and
                                    Accessories
                                   KTT--Appliance, Fixation, Nail/Blade/
                                    Plate Combination, Multiple
                                    Component
    OR           888.3040          Smooth or Threaded Metallic Bone
                                    Fixation Fastener
                                   JEC--Component, Traction, Invasive
                                   HTY--Pin, Fixation, Smooth
                                   JDW--Pin, Fixation, Threaded
Selected Dental
 Materials:
    DE           872.3060          Gold-Based Alloys and Precious Metal
                                    Alloys for Clinical Use
                                   EJT--Alloy, Gold Based, For Clinical
                                    Use
                                   EJS--Alloy, Precious Metal, For
                                    Clinical Use
    DE           872.3200          Resin Tooth Bonding Agent
                                    KLE--Agent, Tooth Bonding, Resin
    DE           872.3275          Dental Cement
                                   EMA--Cement, Dental
                                   EMB--Zinc Oxide Eugenol
    DE           872.3660          Impression Material
                                   ELW--Material, Impression
    DE           872.3690          Tooth Shade Resin Material
                                   EBF--Material, Tooth Shade, Resin
    DE            872.3710         Base Metal Alloy
                                   EJH--Metal, Base
Latex Condoms:
    OB           884.5300          Condom
                                   HIS--Condom
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other
  medical device identifiers may be viewed on FDA's Internet Web Site at
  ``http://www.fda.gov/cdrh/prodcode.html''.

[[Page 17761]]

  Table 3.--Medical Devices for Possible Inclusion in Scope of Product
                  Coverage During Operational Period\1\
------------------------------------------------------------------------
  Product Family   21 CFR Section No     Device Name          Tier
------------------------------------------------------------------------
Anesthesiology
 Panel
    Anesthesia     868.5160           Gas machine for   2
     Devices                           anesthesia or
                                       analgesia
                   868.5270           Breathing system  2
                                       heater
                   868.5440           Portable oxygen   2
                                       generator
                   868.5450           Respiratory gas   2
                                       humidifier
                   868.5630           Nebulizer         2
                   868.5710           Electrically       2
                                       powered oxygen
                                       tent
                   868.5880           Anesthetic        2
                                       vaporizer
    Gas Analyser   868.1040           Powered           2
                                       Algesimeter
                   868.1075           Argon gas         2
                                       analyzer
                   868.1400           Carbon dioxide    2
                                       gas analyzer
                   868.1430           Carbon monoxide   2
                                       gas analyzer
                   868.1500           Enflurane gas     2
                                       analyzer
                   868.1620           Halothane gas     2
                                       analyzer
                   868.1640           Helium gas        2
                                       analyzer
                   868.1670           Neon gas          2
                                       analyzer
                   868.1690           Nitrogen gas      2
                                       analyzer
                   868.1700           Nitrous oxide     2
                                       gas analyzer
                   868.1720           Oxygen gas        2
                                       analyzer
                   868.1730           Oxygen uptake     2
                                       computer
    Peripheral     868.2775           Electrical        2
     Nerve                             peripheral
     Stimulators                       nerve
                                       stimulator
    Respiratory    868.1750           Pressure          2
     Monitoring                        plethysmograph
                   868.1760           Volume            2
                                       plethysmograph
                   868.1780           Inspiratory       2
                                       airway pressure
                                       meter
                   868.1800           Rhinoanemometer   2
                   868.1840           Diagnostic        2
                                       spirometer
                   868.1850           Monitoring        2
                                       spirometer
                   868.1860           Peak-flow meter   2
                                       for spirometry
                   868.1880           Pulmonary-        2
                                       function data
                                       calculator
                   868.1890           Predictive        2
                                       pulmonary-
                                       function value
                                       calculator
                   868.1900           Diagnostic        2
                                       pulmonary-
                                       function
                                       interpretation
                                       calculator
                   868.2025           Ultrasonic air    2
                                       embolism
                                       monitor
                   868.2375           Breathing         2
                                       frequency
                                       monitor (except
                                       apnea
                                       detectors)
                   868.2480           Cutaneous carbon  2
                                       dioxide (PcCO<INF>2)
                                       monitor
                   868.2500           Cutaneous oxygen  2
                                       monitor (for an
                                       infant not
                                       under gas
                                       anesthesia)
                   868.2550           Pneumotachomomet  2
                                       er
                   868.2600           Airway pressure   2
                                       monitor
                   868.5665           Powered           2
                                       percussor
                   868.5690           Incentive         2
                                       spirometer
    Ventilator     868.5905           Noncontinuous     2
                                       ventilator
                                       (IPPB)
                   868.5925           Powered           2
                                       emergency
                                       ventilator
                   868.5935           External          2
                                       negative
                                       pressure
                                       ventilator
                   868.5895           Continuous        2
                                       ventilator
                   868.5955           Intermittent      2
                                       mandatory
                                       ventilation
                                       attachment
                   868.6250           Portable air      2
                                       compressor
Cardiovascular
 Panel
    Cardiovascula  870.1425           Programmable      2
     r Diagnostic                      diagnostic
                                       computer
                   870.1450           Densitometer      2
                   870.2310           Apex cardiograph  2
                                       (vibrocardiogra
                                       ph)
                   870.2320           Ballistocardiogr  2
                                       aph
                   870.2340           Electrocardiogra  2
                                       ph
                   870.2350           Electrocardiogra  1
                                       ph lead
                                       switching
                                       adaptor
                   870.2360           Electrocardiogra  2
                                       ph electrode
                   870.2370           Electrocardiogra  2
                                       ph surface
                                       electrode
                                       tester
                   870.2400           Vectorcardiograp  1
                                       h
                   870.2450           Medical cathode-  1
                                       ray tube
                                       display

[[Page 17762]]


                   870.2675           Oscillometer      2
                   870.2840           Apex              2
                                       cardiographic
                                       transducer
                   870.2860           Heart sound       2
                                       transducer
    Cardiovascula                     Valve, pressure
     r Monitoring                      relief,
                                       cardiopulmonary
                                       bypass
                   870.1100           Blood pressure    2
                                       alarm
                   870.1110           Blood pressure    2
                                       computer
                   870.1120           Blood pressure    2
                                       cuff
                   870.1130           Noninvasive       2
                                       blood pressure
                                       measurement
                                       system
                   870.1140           Venous blood      2
                                       pressure
                                       manometer
                   870.1220           Electrode         2
                                       recording
                                       catheter or
                                       electrode
                                       recording probe
                   870.1270           Intracavitary     2
                                       phonocatheter
                                       system
                   870.1875           Stethoscope       2
                                       (electronic)
                   870.2050           Biopotential      2
                                       amplifier and
                                       signal
                                       conditioner
                   870.2060           Transducer        2
                                       signal
                                       amplifier and
                                       conditioner
                   870.2100           Cardiovascular    2
                                       blood flow-
                                       meter
                   870.2120           Extravascular     2
                                       blood flow
                                       probe
                   870.2300           Cardiac monitor   2
                                       (including
                                       cardiotachomete
                                       r and rate
                                       alarm)
                   870.2700           Oximeter          2
                   870.2710           Ear oximeter      2
                   870.2750           Impedance         2
                                       phlebograph
                   870.2770           Impedance         2
                                       plethysmograph
                   870.2780           Hydraulic,        2
                                       pneumatic, or
                                       photoelectric
                                       plethysmographs
                   870.2850           Extravascular     2
                                       blood pressure
                                       transducer
                   870.2870           Catheter tip      2
                                       pressure
                                       transducer
                   870.2880           Ultrasonic        2
                                       transducer
                   870.2890           Vessel occlusion  2
                                       transducer
                   870.2900           Patient           2
                                       transducer and
                                       electrode cable
                                       (including
                                       connector)
                   870.2910           Radiofrequency    2
                                       physiological
                                       signal
                                       transmitter and
                                       receiver
                   870.2920           Telephone         2
                                       electrocardiogr
                                       aph transmitter
                                       and receiver
                   870.4205           Cardiopulmonary   2
                                       bypass bubble
                                       detector
                   870.4220           Cardiopulmonary   2
                                       bypass heart-
                                       lung machine
                                       console
                   870.4240           Cardiovascular    2
                                       bypass heat
                                       exchanger
                   870.4250           Cardiopulmonary   2
                                       bypass
                                       temperature
                                       controller
                   870.4300           Cardiopulmonary   2
                                       bypass gas
                                       control unit
                   870.4310           Cardiopulmonary   2
                                       bypass coronary
                                       pressure gauge
                   870.4330           Cardiopulmonary   2
                                       bypass on-line
                                       blood gas
                                       monitor
                   870.4340           Cardiopulmonary   2
                                       bypass level
                                       sensing monitor
                                       and/or control
                   870.4370           Roller-type       2
                                       cardiopulmonary
                                       bypass blood
                                       pump
                   870.4380           Cardiopulmonary   2
                                       bypass pump
                                       speed control
                   870.4410           Cardiopulmonary   2
                                       bypass in-line
                                       blood gas
                                       sensor
    Cardiovascula  870.5050           Patient care      2
     r                                 suction
     Therapeutic                       apparatus
                   870.5900           Thermal           2
                                       regulation
                                       system
    Defibrillator  870.5300           DC-               2
                                       defribrillator
                                       (including
                                       paddles)
                   870.5325           Defibrillator     2
                                       tester

[[Page 17763]]


    Echocardiogra  870.2330           Echocardiograph   2
     ph
    Pacemaker &    870.1750           External          2
     Accessories                       programmable
                                       pacemaker pulse
                                       generator
                   870.3630           Pacemaker         2
                                       generator
                                       function
                                       analyzer
                   870.3640           Indirect          2
                                       pacemaker
                                       generator
                                       function
                                       analyzer
                   870.3720           Pacemaker         2
                                       electrode
                                       function tester
    Miscellaneous  870.1800           Withdrawal-       2
                                       infusion pump
                   870.2800           Medical magnetic  2
                                       tape recorder
                   None               Batteries,
                                       rechargeable,
                                       class II
                                       devices
Dental Panel
    Dental         872.1720           Pulp tester       2
     Equipment
                   872.1740           Caries detection  2
                                       device
                   872.4120           Bone cutting      2
                                       instrument and
                                       accessories
                   872.4465           Gas-powered jet   2
                                       injector
                   872.4475           Spring-powered    2
                                       jet injector
                   872.4600           Intraoral         2
                                       ligature and
                                       wire lock
                   872.4840           Rotary scaler     2
                   872.4850           Ultrasonic        2
                                       scaler
                   872.4920           Dental            2
                                       electrosurgical
                                       unit and
                                       accessories
                   872.6070           Ultraviolet       2
                                       activator for
                                       polymerization
                   872.6350           Ultraviolet       2
                                       detector
    Dental         872.3050           Amalgam alloy     2
     Material
                   872.3060           Gold-based        2
                                       alloys and
                                       precious metal
                                       alloys for
                                       clinical use
                   872.3200           Resin tooth       2
                                       bonding agent
                   872.3250           Calcium           2
                                       hydroxide
                                       cavity liner
                   872.3260           Cavity varnish    2
                   872.3275           Dental cement     2
                                       (other than
                                       zinc oxide-
                                       eugenol)
                   872.3300           Hydrophilic       2
                                       resin coating
                                       for dentures
                   872.3310           Coating material  2
                                       for resin
                                       fillings
                   872.3590           Preformed         2
                                       plastic denture
                                       tooth
                   872.3660           Impression        2
                                       material
                   872.3690           Tooth shade       2
                                       resin material
                   872.3710           Base metal alloy  2
                   872.3750           Bracket adhesive  2
                                       resin and tooth
                                       conditioner
                   872.3760           Denture           2
                                       relining,
                                       repairing, or
                                       rebasing resin
                   872.3765           Pit and fissure   2
                                       sealant and
                                       conditioner
                   872.3770           Temporary crown   2
                                       and bridge
                                       resin
                   872.3820           Root canal        2
                                       filling resin
                                       (other than
                                       chloroform use)
                   872.3920           Porcelain tooth   2
    Dental X-ray   872.1800           Extraoral source  2
                                       x-ray system
                   872.1810           Intraoral source  2
                                       x-ray system
     Dental        872.4880           Intraosseous      2
     Implants                          fixation screw
                                       or wire
                   872.3890           Endodontic        2
                                       stabilizing
                                       splint
    Orthodontic    872.5470           Orthodontic       2
                                       plastic bracket
Ear/Nose/Throat
 Panel
    Diagnostic     874.1050           Audiometer        2
     Equipment
                   874.1090           Auditory          2
                                       impedance
                                       tester
                   874.1120           Electronic noise  2
                                       generator for
                                       audiometric
                                       testing
                   874.1325           Electroglottogra  2
                                       ph
                   874.1820           Surgical nerve    2
                                       stimulator/
                                       locator
    Hearing Aids   874.3300           Hearing aid (for  2
                                       bone-
                                       conduction)
                   874.3310           Hearing aid       2
                                       calibrator and
                                       analysis system
                   874.3320           Group hearing     2
                                       aid or group
                                       auditory
                                       trainer

[[Page 17764]]


                   874.3330           Master hearing    2
                                       aid
    Surgical       874.4250           Ear, nose, and    1
     Equipment                         throat electric
                                       or pneumatic
                                       surgical drill
                   874.4490           Argon laser for   2
                                       otology,
                                       rhinology, and
                                       laryngology
                   874.4500           Ear, nose, and    2
                                       throat
                                       microsurgical
                                       carbon dioxide
                                       laser
Gastroenterology/
 Urology Panel
    Endoscope      876.1500           Endoscope and     2
     (including                        accessories
     angioscopes,
     laparscopes,
     ophthalmic
     endoscopes)
                   876.4300           Endoscopic        2
                                       electrosurgical
                                       unit and
                                       accessories
    Gastroenterol  876.1725           Gastrointestinal  1
     ogy                               motility
                                       monitoring
                                       system
    Hemodialysis   876.5600           Sorbent           2
                                       regenerated
                                       dialysate
                                       delivery system
                                       for
                                       hemodialysis
                   876.5630           Peritoneal        2
                                       dialysis system
                                       and accessories
                   876.5665           Water             2
                                       purification
                                       system for
                                       hemodialysis
                   876.5820            Hemodialysis     2
                                       system and
                                       accessories
                   876.5830           Hemodialyzer      2
                                       with disposable
                                       insert (kiil-
                                       type)
    Lithotriptor   876.4500           Mechanical        2
                                       lithotriptor
    Urology        876.1620           Urodynamics       2
     Equipment                         measurement
                                       system
                   876.5320           Nonimplanted      2
                                       electrical
                                       continence
                                       device
                   876.5880           Isolated kidney   2
                                       perfusion and
                                       transport
                                       system and
                                       accessories
General Hospital
 Panel
    Infusion       880.2420           Electronic        2
     Pumps and                         monitor for
     Systems                           gravity flow
                                       infusion
                                       systems
                   880.2460           Electrically      2
                                       powered spinal
                                       fluid pressure
                                       monitor
                   880.5430           Nonelectrically   2
                                       powered fluid
                                       injector
                   880.5725           Infusion pump     2
    Neonatal       880.5400           Neonatal          2
     Incubators                        incubator
                   880.5410           Neonatal          2
                                       transport
                                       incubator
                   880.5700           Neonatal          2
                                       phototherapy
                                       unit
    Piston         880.5570           Hypodermic        1
     Syringes                          single lumen
                                       needle
                   880.5860           Piston syringe    1
                                       (except
                                       antistick)
                   880.6920           Syringe needle    2
                                       introducer
    Miscellaneous  880.2910           Clinical          2
                                       electronic
                                       thermometer
                   880.2920           Clinical mercury  2
                                       thermometer
                   880.5100           AC-powered        1
                                       adjustable
                                       hospital bed
                   880.5500           AC-powered        2
                                       patient lift
                   880.6880           Steam sterilizer  2
                                       (greater than 2
                                       cubic feet)
Neurology Panel
                   882.1020           Rigidity          2
                                       analyzer
                   882.1610           Alpha monitor     2
    Neuro-         882.1320           Cutaneous         2
     Diagnostic                        electrode
                   882.1340           Nasopharyngeal    2
                                       electrode
                   882.1350           Needle electrode  2
                   882.1400           Electroencephalo  2
                                       graph
                   882.1460           Nystagmograph     2
                   882.1480           Neurological      2
                                       endoscope
                   882.1540           Galvanic skin     2
                                       response
                                       measurement
                                       device
                   882.1550           Nerve conduction  2
                                       velocity
                                       measurement
                                       device
                   882.1560           Skin potential    2
                                       measurement
                                       device
                   882.1570           Powered direct-   2
                                       contact
                                       temperature
                                       measurement
                                       device

[[Page 17765]]


                   882.1620           Intracranial      2
                                       pressure
                                       monitoring
                                       device
                   882.1835           Physiological     2
                                       signal
                                       amplifier
                   882.1845           Physiological     2
                                       signal
                                       conditioner
                   882.1855           Electroencephalo  2
                                       gram (EEG)
                                       telemetry
                                       system
                   882.5050           Biofeedback       2
                                       device
    Echoencephalo  882.1240           Echoencephalogra  2
     graphy                            ph
    RPG            882.4400           Radiofrequency    2
                                       lesion
                                       generator
    Neuro Surgery  none               Electrode,        2
                                       spinal epidural
                   882.4305           Powered compound  2
                                       cranial drills,
                                       burrs,
                                       trephines, and
                                       their
                                       accessories
                   882.4310           Powered simple    2
                                       cranial drills
                                       burrs,
                                       trephines, and
                                       their
                                       accessories
                   882.4360           Electric cranial  2
                                       drill motor
                   882.4370           Pneumatic         2
                                       cranial drill
                                       motor
                   882.4560           Stereotaxic       2
                                       instrument
                   882.4725           Radiofrequency    2
                                       lesion probe
                   882.4845           Powered rongeur   2
                   882.5500           Lesion            2
                                       temperature
                                       monitor
    Stimulators    882.1870           Evoked response   2
                                       electrical
                                       stimulator
                   882.1880           Evoked response   2
                                       mechanical
                                       stimulator
                   882.1890           Evoked response   2
                                       photic
                                       stimulator
                   882.1900           Evoked response   2
                                       auditory
                                       stimulator
                   882.1950           Tremor            2
                                       transducer
                   882.5890           Transcutaneous    2
                                       electrical
                                       nerve
                                       stimulator for
                                       pain relief
Obstetrics/
 Gynecology Panel
    Fetal          884.1660           Transcervical     2
     Monitoring                        endoscope
                                       (amnioscope)
                                       and accessories
                   884.1690           Hysteroscope and  2
                                       accessories
                                       (for
                                       performance
                                       standards)
                   884.2225           Obstetric-        2
                                       gynecologic
                                       ultrasonic
                                       imager
                   884.2600           Fetal cardiac     2
                                       monitor
                   884.2640           Fetal             2
                                       phonocardiograp
                                       hic monitor and
                                       accessories
                   884.2660           Fetal ultrasonic  2
                                       monitor and
                                       accessories
                   884.2675           Fetal scalp       1
                                       circular
                                       (spiral)
                                       electrode and
                                       applicator
                   884.2700           Intrauterine      2
                                       pressure
                                       monitor and
                                       accessories
                   884.2720           External uterine  2
                                       contraction
                                       monitor and
                                       accessories
                   884.2740           Perinatal         2
                                       monitoring
                                       system and
                                       accessories
                   884.2960           Obstetric         2
                                       ultrasonic
                                       transducer and
                                       accessories
    Gynecological  884.1720           Gynecologic       2
     Surgery                           laparoscope and
     Equipment                         accessories
                   884.4160           Unipolar          2
                                       endoscopic
                                       coagulator-
                                       cutter and
                                       accessories
                   884.4550           Gynecologic       2
                                       surgical laser
                   884.4120           Gynecologic       2
                                       electrocautery
                                       and accessories
                   884.5300           Condom            2
    Ophthalmic     886.3320           Eye sphere        2
     Implants                          implant
    Contact Lens   886.1385           Polymethylmethac  2
                                       rylate (PMMA)
                                       diagnostic
                                       contact lens
                   886.5916           Rigid gas         2
                                       permeable
                                       contact lens
                                       (daily wear
                                       only)
    Diagnostic     886.1120           Opthalmic camera  1
     Equipment
                   886.1220           Corneal           1
                                       electrode
                   886.1250           Euthyscope (AC-   1
                                       powered)
                   886.1360           Visual field      1
                                       laser
                                       instrument

[[Page 17766]]


                   886.1510           Eye movement      1
                                       monitor
                   886.1570           Ophthalmoscope    1
                   886.1630           AC-powered        1
                                       photostimulator
                   886.1640           Ophthalmic        1
                                       preamplifier
                   886.1670           Ophthalmic        2
                                       isotope uptake
                                       probe
                   886.1780           Retinoscope (AC-  1
                                       powered device)
                   886.1850           AC-powered slit   1
                                       lamp
                                       biomicroscope
                   886.1930           Tonometer and     2
                                       accessories
                   886.1945           Transilluminator  1
                                       (AC-powered
                                       device)
                   886.3130           Ophthalmic        2
                                       conformer
    (Diagnostic/   886.4670           Phacofragmentati  2
     Surgery                           on system
     Equipment)
     Ophthalmic    886.3340           Extraocular       2
     Implants                          orbital implant
                   886.3800           Scleral shell     2
    Surgical        880.5725          Infusion pump     2
     Equipment                         (performance
                                       standards)
                   886.3100           Ophthalmic        2
                                       tantalum clip
                   886.3300           Absorbable        2
                                       implant
                                       (scleral
                                       buckling
                                       method)
                   886.4100           Radiofrequency    2
                                       electrosurgical
                                       cautery
                                       apparatus
                   886.4115           Thermal cautery   2
                                       unit
                   886.4150           Vitreous          2
                                       aspiration and
                                       cutting
                                       instrument
                   886.4170           Cryophthalmic     2
                                       unit
                   886.4250           Ophthalmic        1
                                       electrolysis
                                       unit (AC-
                                       powered device)
                   886.4335           Operating         1
                                       headlamp (AC-
                                       powered device)
                   886.4390           Ophthalmic laser  2
                   886.4392           Nd:YAG laser for  2
                                       posterior
                                       capsulotomy
                   886.4400           Electronic metal  1
                                       locator
                   886.4440           AC-powered        1
                                       magnet
                   886.4610           Ocular pressure   2
                                       applicator
                   886.4690           Ophthalmic        2
                                       photocoagulator
                   886.4790           Ophthalmic        2
                                       sponge
                   886.5100           Ophthalmic beta   2
                                       radiation
                                       source
                   none               Ophthalmoscopes,  1
                                       replacement
                                       batteries, hand-
                                       held
Orthopedic Panel
    Implants       888.3010           Bone fixation     2
                                       cerclage
                   888.3020           Intramedullary    2
                                       fixation rod
                   888.3030           Single/multiple   2
                                       component
                                       metallic bone
                                       fixation
                                       appliances and
                                       accessories
                   888.3040           Smooth or         2
                                       threaded
                                       metallic bone
                                       fixation
                                       fastener
                   888.3050           Spinal            2
                                       interlaminal
                                       fixation
                                       orthosis
                   888.3060           Spinal            2
                                       intervertebral
                                       body fixation
                                       orthosis
    Surgical       888.1240           AC-powered        2
     Equipment                         dynamometer
                   888.4580           Sonic surgical    2
                                       instrument and
                                       accessories/
                                       attachments
                   none               Accessories,      2
                                       fixation,
                                       spinal
                                       interlaminal
                   none               Accessories,      2
                                       fixation,
                                       spinal
                                       intervertebral
                                       body
                   none               Monitor,          1
                                       pressure,
                                       intracompartmen
                                       tal
                   none               Orthosis,         2
                                       fixation,
                                       spinal
                                       intervertebral
                                       fusion
                   none               Orthosis, spinal
                                       pedicle
                                       fixation
                   none               System, cement    1
                                       removal
                                       extraction

[[Page 17767]]


Physical Medicine
 Panel
    Diagnostic     890.1225           Chronaximeter     2
     Equipment or
     (Therapy)
     Therapeutic
     Equipment
                   890.1375           Diagnostic        2
                                       electromyograph
                   890.1385           Diagnostic        2
                                       electromyograph
                                       needle
                                       electrode
                   890.1450           Powered reflex    2
                                       hammer
                   890.1850           Diagnostic        2
                                       muscle
                                       stimulator
    or (Therapy)   890.5850           Powered muscle    2
                                       stimulator
    Therapeutic    890.5100           Immersion         2
     Equipment                         hydrobath
                   890.5110           Paraffin bath     2
                   890.5500           Infrared lamp     2
                   890.5720           Water             2
                                       circulating hot
                                       or cold pack
                   890.5740           Powered heating   2
                                       pad
Radiology Panel
    MRI            892.1000           Magnetic          2
                                       resonance
                                       diagnostic
                                       device
    Ultrasound     884.2660           Fetal ultrasonic  2
     Diagnostic                        monitor and
                                       accessories
                   892.1540           Nonfetal
                                       ultrasonic
                                       monitor
                   892.1560           Ultrasonic        2
                                       pulsed echo
                                       imaging system
                   892.1570           Diagnostic        2
                                       ultrasonic
                                       transducer
                   892.1550           Ultrasonic
                                       pulsed doppler
                                       imaging system
    Angiographic   892.1600           Angiographic x-   2
                                       ray system
    Diagnostic X-  892.1610           Diagnostic x-ray  2
     Ray                               beam-limiting
                                       device
                   892.1620           Cine or spot      2
                                       fluorographic x-
                                       ray camera
                   892.1630           Electrostatic x-  2
                                       ray imaging
                                       system
                   892.1650           Image-            2
                                       intensified
                                       fluoroscopic x-
                                       ray system
                   892.1670           Spot film device  2
                   892.1680           Stationary x-ray  2
                                       system
                   892.1710           Mammographic x-   2
                                       ray system
                   892.1720           Mobile x-ray      2
                                       system
                   892.1740           Tomographic x-    1
                                       ray system
                   892.1820           Pneumoencephalog  2
                                       raphic chair
                   892.1850           Radiographic      1
                                       film cassette
                   892.1860           Radiographic      1
                                       film/cassette
                                       changer
                   892.1870           Radiographic      2
                                       film/cassette
                                       changer
                                       programmer
                   892.1900           Automatic         2
                                       radiographic
                                       film processor
                   892.1980           Radiologic table  1
    CT Scanner     892.1750           Computed          2
                                       tomography x-
                                       ray system
    Radiation      892.5050           Medical charged-  2
     Therapy                           particle
                                       radiation
                                       therapy system
                   892.5300           Medical neutron   2
                                       radiation
                                       therapy system
                   892.5700           Remote            2
                                       controlled
                                       radionuclide
                                       applicator
                                       system
                   892.5710           Radiation         2
                                       therapy beam-
                                       shaping block
                   892.5730           Radionuclide      2
                                       brachytherapy
                                       source
                   892.5750           Radionuclide      2
                                       radiation
                                       therapy system
                   892.5770           Powered           2
                                       radiation
                                       therapy patient
                                       support
                                       assembly
                   892.5840           Radiation         2
                                       therapy
                                       simulation
                                       system
                   892.5930           Therapeutic x-    1
                                       ray tube
                                       housing
                                       assembly
    Nuclear        892.1170           Bone              2
     Medicine                          densitometer
                   892.1200           Emission          2
                                       computed
                                       tomography
                                       system

[[Page 17768]]


                   892.1310           Nuclear           1
                                       tomography
                                       system
                   892.1390           Radionuclide      2
                                       rebreathing
                                       system
General/Plastic
 Surgery Panel
    Surgical       878.4630           Ultraviolet lamp  2
     Lamps                             for
                                       dermatologic
                                       disorders
                   890.5500           Infrared lamp     2
                   878.4580           Surgical lamp     2
    Electrosurgic  878.4810           Laser surgical    2
     al Cutting                        instrument for
     Equipment                         use in general
                                       and plastic
                                       surgery and in
                                       dermatology
                   878.4400           Electrosurgical   2
                                       cutting and
                                       coagulation
                                       device and
                                       accessories
    Miscellaneous  878.4780           Powered suction   2
                                       pump
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other
  medical device identifiers may be viewed on FDA's Internet Web Site at
  ``http://www.fda.gov/cdrh/prodcode.html''.

Appendix C of Subpart B [Reserved]

Appendix D of Subpart B [Reserved]

Appendix E of Subpart B [Reserved]

Appendix F of Subpart B [Reserved]

Subpart C--Framework or ``Umbrella'' Provisions

Sec. 26.60  Definitions.

    (a) The following terms and definitions shall apply to this part
only:
    (1) Designating Authority means a body with power to designate,
monitor, suspend, remove suspension of, or withdraw conformity
assessment bodies as specified under this part.
    (2) Designation means the identification by a designating authority
of a conformity assessment body to perform conformity assessment
procedures under this part.
    (3) Regulatory Authority means a government agency or entity that
exercises a legal right to control the use or sale of products within a
party's jurisdiction and may take enforcement action to ensure that
products marketed within its jurisdiction comply with legal
requirements.
    (b) Other terms concerning conformity assessment used in this part
shall have the meaning given elsewhere in this part or in the
definitions contained in Guide 2 (1996 edition) of the International
Organization for Standardization (ISO) and the International
Electrotechnical Commission (IEC). In the event of an inconsistency
between the ISO/IEC Guide 2 and definitions in this part, the
definitions in this part shall prevail. The ISO/IEC Guide 2 is
incorporated by reference with the approval of the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies are available from the International Organization for
Standardization, 1, rue de Varembe, Case postale 56, CH-1211 Geneve 20,
Switzerland, or on the Internet at ``http://www.iso.ch'' or may be
examined at the Food and Drug Administration's Medical Library, 5600
Fishers Lane, rm. 11B-40, Rockville, MD 20857, or the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

Sec. 26.61  Purpose of this part.

     This part specifies the conditions by which each party will accept
or recognize results of conformity assessment procedures, produced by
the other party's conformity assessment bodies (CAB's) or authorities,
in assessing conformity to the importing party's requirements, as
specified on a sector-specific basis in subparts A and B of this part,
and to provide for other related cooperative activities. The objective
of such mutual recognition is to provide effective market access
throughout the territories of the parties with regard to conformity
assessment for all products covered under this part. If any obstacles
to such access arise, consultations will promptly be held. In the
absence of a satisfactory outcome of such consultations, the party
alleging its market access has been denied, may, within 90 days of such
consultation, invoke its right to terminate this part in accordance
with Sec. 26.80.

Sec. 26.62  General obligations.

    (a) The United States shall, as specified in subparts A and B of
this part, accept or recognize results of specified procedures, used in
assessing conformity to specified legislative, regulatory, and
administrative provisions of the United States, produced by the other
party's conformity assessment bodies (CAB's) and/or authorities.
    (b) The European Community (EC) and its Member States shall, as
specified in subparts A and B of this part, accept or recognize results
of specified procedures, used in assessing conformity to specified
legislative, regulatory, and administrative provisions of the EC and
its Member States, produced by the other party's CAB's and/or
authorities.
    (c) Where sectoral transition arrangements have been specified in
subparts A and B of this part, the above obligations will apply
following the successful completion of those sectoral transition
arrangements, with the understanding that the conformity assessment
procedures utilized assure conformity to the satisfaction of the
receiving party, with applicable legislative, regulatory, and
administrative provisions of that party, equivalent to the assurance
offered by the receiving party's own procedures.

Sec. 26.63   General coverage of this part.

    (a) This part applies to conformity assessment procedures for
products and/or processes and to other related cooperative activities
as described in this part.
    (b) Subparts A and B of this part may include:
    (1) A description of the relevant legislative, regulatory, and
administrative provisions pertaining to the conformity assessment
procedures and technical regulations;
    (2) A statement on the product scope and coverage;
    (3) A list of designating authorities;
    (4) A list of agreed conformity assessment bodies (CAB's) or
authorities or a source from which to obtain a list of such bodies or
authorities and a statement of the scope of the conformity assessment
procedures for which each has been agreed;
    (5) The procedures and criteria for designating the CAB's;

[[Page 17769]]

    (6) A description of the mutual recognition obligations;
    (7) A sectoral transition arrangement;
    (8) The identity of a sectoral contact point in each party's
territory; and
    (9) A statement regarding the establishment of a Joint Sectoral
Committee.
    (c) This part shall not be construed to entail mutual acceptance of
standards or technical regulations of the parties and, unless otherwise
specified in subpart A or B of this part, shall not entail the mutual
recognition of the equivalence of standards or technical regulations.

Sec. 26.64   Transitional arrangements.

    The parties agree to implement the transitional commitments on
confidence building as specified in subparts A and B of this part.
    (a) The parties agree that each sectoral transitional arrangement
shall specify a time period for completion.
    (b) The parties may amend any transitional arrangement by mutual
agreement.
    (c) Passage from the transitional phase to the operational phase
shall proceed as specified in subparts A and B of this part, unless
either party documents that the conditions provided in such subpart for
a successful transition are not met.

Sec. 26.65   Designating authorities.

    The parties shall ensure that the designating authorities specified
in subpart B of this part have the power and competence in their
respective territories to carry out decisions under this part to
designate, monitor, suspend, remove suspension of, or withdraw
conformity assessment bodies (CAB's).

Sec. 26.66   Designation and listing procedures.

    The following procedures shall apply with regard to the designation
of conformity assessment bodies (CAB's) and the inclusion of such
bodies in the list of CAB's in subpart B of this part:
    (a) The designating authority identified in subpart B of this part
shall designate CAB's in accordance with the procedures and criteria
set forth in subpart B of this part;
    (b) A party proposing to add a CAB to the list of such bodies in
subpart B of this part shall forward its proposal of one or more
designated CAB's in writing to the other party with a view to a
decision by the Joint Committee;
    (c) Within 60 days following receipt of the proposal, the other
party shall indicate its position regarding either its confirmation or
its opposition. Upon confirmation, the inclusion in subpart B of this
part of the proposed CAB or CAB's shall take effect; and
    (d) In the event that the other party contests on the basis of
documented evidence the technical competence or compliance of a
proposed CAB, or indicates in writing that it requires an additional 30
days to more fully verify such evidence, such CAB shall not be included
on the list of CAB's in subpart B of this part. In this instance, the
Joint Committee may decide that the body concerned be verified. After
the completion of such verification, the proposal to list the CAB in
subpart B may be resubmitted to the other party.

Sec. 26.67  Suspension of listed conformity assessment bodies.

    The following procedures shall apply with regard to the suspension
of a conformity assessment body (CAB) listed in subpart B of this part.
    (a) A party shall notify the other party of its contestation of the
technical competence or compliance of a CAB listed in subpart B of this
part and the contesting party's intent to suspend such CAB. Such
contestation shall be exercised when justified in an objective and
reasoned manner in writing to the other party;
    (b) The CAB shall be given prompt notice by the other party and an
opportunity to present information in order to refute the contestation
or to correct the deficiencies which form the basis of the
contestation;
    (c) Any such contestation shall be discussed between the parties in
the Joint Sectoral Committee described in subpart B of this part. If
there is no Joint Sectoral Committee, the contesting party shall refer
the matter directly to the Joint Committee. If agreement to suspend is
reached by the Joint Sectoral Committee or, if there is no Joint
Sectoral Committee, by the Joint Committee, the CAB shall be suspended;
    (d) Where the Joint Sectoral Committee or Joint Committee decides
that verification of technical competence or compliance is required, it
shall normally be carried out in a timely manner by the party in whose
territory the body in question is located, but may be carried out
jointly by the parties in justified cases;
    (e) If the matter has not been resolved by the Joint Sectoral
Committee within 10 days of the notice of contestation, the matter
shall be referred to the Joint Committee for a decision. If there is no
Joint Sectoral Committee, the matter shall be referred directly to the
Joint Committee. If no decision is reached by the Joint Committee
within 10 days of the referral to it, the CAB shall be suspended upon
the request of the contesting party;
    (f) Upon the suspension of a CAB listed in subpart B of this part,
a party is no longer obligated to accept or recognize the results of
conformity assessment procedures performed by that CAB subsequent to
suspension. A party shall continue to accept the results of conformity
assessment procedures performed by that CAB prior to suspension, unless
a regulatory authority of the party decides otherwise based on health,
safety or environmental considerations or failure to satisfy other
requirements within the scope of subpart B of this part; and
    (g) The suspension shall remain in effect until agreement has been
reached by the parties upon the future status of that body.

Sec. 26.68   Withdrawal of listed conformity assessment bodies.

    The following procedures shall apply with regard to the withdrawal
from subpart B of this part of a conformity assessment body (CAB):
    (a) A party proposing to withdraw a CAB listed in subpart B of this
part shall forward its proposal in writing to the other party;
    (b) Such CAB shall be promptly notified by the other party and
shall be provided a period of at least 30 days from receipt to provide
information in order to refute or to correct the deficiencies which
form the basis of the proposed withdrawal;
    (c) Within 60 days following receipt of the proposal, the other
party shall indicate its position regarding either its confirmation or
its opposition. Upon confirmation, the withdrawal from the list in
subpart B of this part of the CAB shall take effect;
    (d) In the event the other party opposes the proposal to withdraw
by supporting the technical competence and compliance of the CAB, the
CAB shall not at that time be withdrawn from the list of CAB's in
subpart B of this part. In this instance, the Joint Sectoral Committee
or the Joint Committee may decide to carry out a joint verification of
the body concerned. After the completion of such verification, the
proposal for withdrawal of the CAB may be resubmitted to the other
party; and
    (e) Subsequent to the withdrawal of a CAB listed in subpart B of
this part, a party shall continue to accept the results of conformity
assessment procedures performed by that CAB prior to withdrawal, unless
a regulatory authority of the party decides otherwise based on health,
safety, and environmental considerations or failure to satisfy other
requirements within the scope of subpart B of this part.

[[Page 17770]]

Sec. 26.69   Monitoring of conformity assessment bodies.

    The following shall apply with regard to the monitoring of
conformity assessment bodies (CAB's) listed in subpart B of this part:
    (a) Designating authorities shall assure that their CAB's listed in
subpart B of this part are capable and remain capable of properly
assessing conformity of products or processes, as applicable, and as
covered in subpart B of this part. In this regard, designating
authorities shall maintain, or cause to maintain, ongoing surveillance
over their CAB's by means of regular audit or assessment;
    (b) The parties undertake to compare methods used to verify that
the CAB's listed in subpart B of this part comply with the relevant
requirements of subpart B of this part. Existing systems for the
evaluation of CAB's may be used as part of such comparison procedures;
    (c) Designating authorities shall consult as necessary with their
counterparts, to ensure the maintenance of confidence in conformity
assessment procedures. With the consent of both parties, this
consultation may include joint participation in audits/inspections
related to conformity assessment activities or other assessments of
CAB's listed in subpart B of this part; and
    (d) Designating authorities shall consult, as necessary, with the
relevant regulatory authorities of the other party to ensure that all
technical requirements are identified and are satisfactorily addressed.

Sec. 26.70   Conformity assessment bodies.

    Each party recognizes that the conformity assessment bodies (CAB's)
listed in subpart B of this part fulfill the conditions of eligibility
to assess conformity in relation to its requirements as specified in
subpart B of this part. The parties shall specify the scope of the
conformity assessment procedures for which such bodies are listed.

Sec. 26.71   Exchange of information.

    (a) The parties shall exchange information concerning the
implementation of the legislative, regulatory, and administrative
provisions identified in subparts A and B of this part.
    (b) Each party shall notify the other party of legislative,
regulatory, and administrative changes related to the subject matter of
this part at least 60 days before their entry into force. Where
considerations of safety, health or environmental protection require
more urgent action, a party shall notify the other party as soon as
practicable.
    (c) Each party shall promptly notify the other party of any changes
to its designating authorities and/or conformity assessment bodies
(CAB's).
    (d) The parties shall exchange information concerning the
procedures used to ensure that the listed CAB's under their
responsibility comply with the legislative, regulatory, and
administrative provisions outlined in subpart B of this part.
    (e) Regulatory authorities identified in subparts A and B of this
part shall consult as necessary with their counterparts, to ensure the
maintenance of confidence in conformity assessment procedures and to
ensure that all technical requirements are identified and are
satisfactorily addressed.

 Sec. 26.72   Sectoral contact points.

    Each party shall appoint and confirm in writing contact points to
be responsible for activities under subparts A and B of this part.

Sec. 26.73   Joint Committee.

    (a) A Joint Committee consisting of representatives of the United
States and the European Community (EC) will be established. The Joint
Committee shall be responsible for the effective functioning of this
part.
    (b) The Joint Committee may establish Joint Sectoral Committees
comprised of appropriate regulatory authorities and others deemed
necessary.
    (c) The United States and the EC shall have one vote in the Joint
Committee. The Joint Committee shall make its decisions by unanimous
consent. The Joint Committee shall determine its own rules and
procedures.
    (d) The Joint Committee may consider any matter relating to the
effective functioning of this part. In particular it shall be
responsible for:
    (1) Listing, suspension, withdrawal and verification of conformity
assessment bodies (CAB's) in accordance with this subpart and subpart B
of this part;
    (2) Amending transitional arrangements in subparts A and B of this
part;
    (3) Resolving any questions relating to the application of this
part not otherwise resolved in the respective Joint Sectoral
Committees;
    (4) Providing a forum for discussion of issues that may arise
concerning the implementation of this part;
    (5) Considering ways to enhance the operation of this part;
    (6) Coordinating the negotiation of additional subparts; and
    (7) Considering whether to amend this part in accordance with
Sec. 26.80.
    (e) When a party introduces new or additional conformity assessment
procedures affecting subpart A or B of this part, the parties shall
discuss the matter in the Joint Committee with a view to bringing such
new or additional procedures within the scope of this part, where
relevant.

 Sec. 26.74   Preservation of regulatory authority.

    (a) Nothing in this part shall be construed to limit the authority
of a party to determine, through its legislative, regulatory, and
administrative measures, the level of protection it considers
appropriate for safety; for protection of human, animal, or plant life
or health; for the environment; for consumers; and otherwise with
regard to risks within the scope of the applicable subpart A or B of
this part.
    (b) Nothing in this part shall be construed to limit the authority
of a regulatory authority to take all appropriate and immediate
measures whenever it ascertains that a product may:
    (1) Compromise the health or safety of persons in its territory;
    (2) Not meet the legislative, regulatory, or administrative
provisions within the scope of the applicable subpart A or B of this
part; or
    (3) Otherwise fail to satisfy a requirement within the scope of the
applicable subpart A or B of this part. Such measures may include
withdrawing the products from the market, prohibiting their placement
on the market, restricting their free movement, initiating a product
recall, and preventing the recurrence of such problems, including
through a prohibition on imports. If the regulatory authority takes
such action, it shall inform its counterpart authority and the other
party within 15 days of taking such action, providing its reasons.

Sec. 26.75   Suspension of recognition obligations.

    Either party may suspend its obligations under subpart A or B of
this part, in whole or in part, if:
    (a) A party suffers a loss of market access for the party's
products within the scope of subpart A or B of this part as a result of
the failure of the other party to fulfill its obligations under this
part;
    (b) The adoption of new or additional conformity assessment
requirements as referenced in Sec. 26.73(e) results in a loss of market
access for the party's products within the scope of subpart B of this
part because conformity assessment bodies (CAB's) designated by the
party in order to meet such requirements have not been recognized by
the party implementing the requirements; or

[[Page 17771]]

    (c) The other party fails to maintain legal and regulatory
authorities capable of implementing the provisions of this part.

Sec. 26.76  Confidentiality.

    (a) Each party agrees to maintain, to the extent required under its
laws, the confidentiality of information exchanged under this part.
    (b) In particular, neither party shall disclose to the public, nor
permit a conformity assessment body (CAB) to disclose to the public,
information exchanged under this part that constitutes trade secrets,
confidential commercial or financial information, or information that
relates to an ongoing investigation.
    (c) A party or a CAB may, upon exchanging information with the
other party or with a CAB of the other party, designate the portions of
the information that it considers to be exempt from disclosure.
    (d) Each party shall take all precautions reasonably necessary to
protect information exchanged under this part from unauthorized
disclosure.

 Sec. 26.77   Fees.

    Each party shall endeavor to ensure that fees imposed for services
under this part shall be commensurate with the services provided. Each
party shall ensure that, for the sectors and conformity assessment
procedures covered under this part, it shall charge no fees with
respect to conformity assessment services provided by the other party.

 Sec. 26.78   Agreements with other countries.

    Except where there is written agreement between the parties,
obligations contained in mutual recognition agreements concluded by
either party with a party not a party to this part (a third party)
shall have no force and effect with regard to the other party in terms
of acceptance of the results of conformity assessment procedures in the
third party.

Sec. 26.79   Territorial application.

    This part shall apply, on the one hand, to the territories in which
the Treaty establishing the European Community (EC) is applied, and
under the conditions laid down in that Treaty and, on the other hand,
to the territory of the United States.

Sec. 26.80  Entry into force, amendment and termination.

    (a) The ``Agreement on Mutual Recognition Between the United States
of America and the European Community,'' from which this part is
derived, including its sectoral annexes on telecommunications
equipment, electromagnetic compatibility, electrical safety,
recreational craft, pharmaceutical GMP inspections, and medical devices
shall enter into force on the first day of the second month following
the date on which the parties have exchanged letters confirming the
completion of their respective procedures for the entry into force of
that agreement.
    (b) That agreement including any sectoral annex may, through the
Joint Committee, be amended in writing by the parties to that
agreement. Those parties may add a sectoral annex upon the exchange of
letters. Such annex shall enter into force 30 days following the date
on which those parties have exchanged letters confirming the completion
of their respective procedures for the entry into force of the sectoral
annex.
    (c) Either party to that agreement may terminate that agreement in
its entirety or any individual sectoral annex thereof by giving the
other party to that agreement 6 months notice in writing. In the case
of termination of one or more sectoral annexes, the parties to that
agreement will seek to achieve by consensus to amend that agreement,
with a view to preserving the remaining Sectoral Annexes, in accordance
with the procedures in this section. Failing such consensus, that
agreement shall terminate at the end of 6 months.
    (d) Following termination of that agreement in its entirety or any
individual sectoral annex thereof, a party to that agreement shall
continue to accept the results of conformity assessment procedures
performed by conformity assessment bodies under that agreement prior to
termination, unless a regulatory authority in the party decides
otherwise based on health, safety and environmental considerations or
failure to satisfy other requirements within the scope of the
applicable sectoral annex.

Sec. 26.81  Final provisions.

    (a) The sectoral annexes referred to in Sec. 26.80(a), as well as
any new sectoral annexes added pursuant to Sec. 26.80(b), shall form an
integral part of the ``Agreement on Mutual Recognition Between the
United States of America and the European Community,'' from which this
part is derived.
    (b) For a given product or sector, the provisions contained in
subparts A and B of this part shall apply in the first place, and the
provisions of subpart C of this part in addition to those provisions.
In the case of any inconsistency between the provisions of subpart A or
B of this part and subpart C of this part, subpart A or B shall
prevail, to the extent of that inconsistency.
    (c) The agreement from which this part is derived shall not affect
the rights and obligations of the parties under any other international
agreement.
    (d) In the case of subpart B of this part, the parties shall review
the status of such subpart at the end of 3 years from entry into force
of subpart B.

    Dated: April 6, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-9486 Filed 4-9-98; 8:45 am]
BILLING CODE 4160-01-F