[Federal Register: March 24, 2003 (Volume 68, Number 56)]
[Rules and Regulations]
[Page 14134-14138]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr03-4]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. 00N-0018]
Medical Devices; Reclassification of the Knee Joint
Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis
and the Knee Joint Femorotibial (Uni-compartmental) Metal/Polymer
Porous-Coated Uncemented Prosthesis
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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[[Page 14135]]
SUMMARY: The Food and Drug Administration (FDA) is announcing that it
has reclassified two fixed-bearing knee joint prostheses, the knee
joint patellofemorotibial metal/polymer porous-coated uncemented
prosthesis, which is intended to be implanted to replace a knee joint,
and the knee joint femorotibial (uni-compartmental) metal/polymer
porous-coated uncemented prosthesis, which is intended to be implanted
to replace part of a knee joint. FDA has reclassified the devices from
class III (premarket approval) into class II (special controls). The
special control that will apply is a guidance document entitled ``Class
II Special Controls Guidance Document: Knee Joint Patellofemorotibial
and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses;
Guidance for Industry and FDA.'' The agency is reclassifying these
devices into class II because special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the devices, and there is sufficient information to
establish special controls. The agency is also announcing that it has
issued an order in the form of a letter to the Orthopedic Surgical
Manufacturers Association (OSMA) reclassifying the devices.
EFFECTIVE DATE: This rule is effective March 24, 2003.
FOR FURTHER INFORMATION CONTACT: Peter G. Allen, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2036.
SUPPLEMENTARY INFORMATION:
I. Regulatory Authorities
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(the SMDA) (Public Law 101-629), and the Food and Drug Administration
Modernization Act of 1997 (FDAMA) (Public Law 105-115), established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the act (21 U.S.C. 360c) established three
categories (classes) of devices, depending on the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f)) of the act (21 U.S.C.
360c(f)) into class III without any FDA rulemaking process. Those
devices remain in class III and require premarket approval, unless and
until: (1) The device is reclassified into class I or II; (2) FDA
issues an order classifying the device into class I or II in accordance
with section 513(f)(2) of the act (21 U.S.C. 360c(f)(2)); or (3) FDA
issues an order finding the device to be substantially equivalent,
under section 513(i) of the act (21 U.S.C. 360c(i)), to a predicate
device that does not require premarket approval. The agency determines
whether new devices are substantially equivalent to previously offered
devices by means of premarket notification (510(k)) procedures in
section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the
regulations (21 CFR part 807).
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
Reclassification of postamendments devices is governed by section
513(f)(3) of the act (21 U.S.C.360c(f)(3)). This section states that
FDA may initiate the reclassification of a device classified into class
III under section 513(f)(1) of the act, or that a manufacturer or
importer of a device may petition the Secretary of Health and Human
Services (the Secretary) for the issuance of an order classifying the
device into class I or class II. FDA's regulations in 21 CFR 860.134
set forth the procedures for the filing and review of a petition for
reclassification of such class III devices. In order to change the
classification of the device, it is necessary that the proposed new
class have sufficient regulatory controls to provide reasonable
assurance of the safety and effectiveness of the device for its
intended use.
Under section 513(f)(3)(B)(i) of the act, the Secretary may, for
good cause shown, refer a petition to a device panel. If a petition is
referred to a panel, the panel shall make a recommendation to the
Secretary respecting approval or denial of the petition. Any such
recommendation shall contain: (1) A summary of the reasons for the
recommendation, (2) a summary of the data upon which the recommendation
is based, and (3) an identification of the risks to health (if any)
presented by the device with respect to which the petition was filed.
II. Recommendations of the Panel
On July 25, 1997, FDA filed a reclassification petition submitted
by OSMA, requesting reclassification of the knee joint
patellofemorotibial metal/polymer porous-coated uncemented prosthesis,
which is intended to be implanted to replace a knee joint, and the knee
joint femorotibial (uni-compartmental) metal/polymer porous-coated
uncemented prosthesis, which is intended to be implanted to replace
part of a knee joint, from class III into class II. FDA consulted with
the Orthopedic and Rehabilitation Devices Panel (the Panel) regarding
the reclassification petition. During a public meeting on January 12
and 13, 1998, the Panel recommended that FDA reclassify these two
devices from class III into class II. The Panel recommended that the
special controls for these devices be FDA guidance documents, consensus
standards, and postmarket surveillance.
FDA considered the Panel's recommendation and tentatively agreed
that these generic types of devices should be reclassified from class
III to class II. FDA agreed with the Panel that guidance documents,
which include the consensus standards, are appropriate special controls
for the devices.
FDA disagreed with the Panel that postmarket surveillance, under
section 522 of the act (21 U.S.C. 3601), is an appropriate special
control for these devices. In their deliberations, the Panel stated
that it was important that adverse device outcomes be reported to FDA
and be followed through postmarket surveillance. However, FDA believes
that another postmarket mechanism better addresses the Panel's concern.
FDA believes that the existing mandatory Medical Device Reporting
system is the appropriate mechanism to report and follow such adverse
events. Therefore, FDA determined that postmarket surveillance under
section 522 of the act is unnecessary to address the Panel's concerns
and to reasonably
[[Page 14136]]
assure the safety and effectiveness of the devices.
Subsequently, in the Federal Register of March 7, 2000 (65 FR
12015), FDA issued the Panel's recommendation for public comment. FDA
received three comments on the notice of panel's recommendation that
supported the Panel's recommendation to reclassify the devices into
class II. FDA agrees with these comments.
One comment also requested the following three changes in the
device identification:
(1) Change the proposed porous coating thickness range from 600 to
1,500 microns to 500 to 1,600 microns ``to increase the potential for
bone ingrowth.''
(2) Change the proposed volume porosity percentage range from 30 to
70 percent to 30 to 80 percent based upon a transcortical animal study
model that demonstrated more bone formation occurred with the use of
higher volume porosity materials than with the use of lower volume
porosity materials
(3) Include in the device identifications a statement that a new
coating material that meets the identification parameters (volume
porosity, average pore size, interconnecting porosity, and porous
coating thickness) and has equivalent performance (demonstrated by
mechanical testing and/or animal studies) can be determined to be
substantially equivalent to a legally currently marketed device without
human clinical information.
FDA agrees that the lower limit of the porous-coating thickness
should be 500 microns not 600 microns. The lower limit of the Panel's
recommendation was 500 microns, but due to a typographical error a
lower limit of 600 microns was printed in the notice of panel
recommendation. FDA is noting and correcting this error. FDA disagrees
with the request to raise the upper limit of the porous coating
thickness range to 1,600 microns because the comment did not provide
any data to support this requested change. FDA notes that a higher
porous coating thickness is not necessarily excluded and that a sponsor
of a new device may submit material characterization information to
demonstrate that a device with a thicker porous coating material is
substantially equivalent to a legally marketed predicate device.
FDA disagrees with the comment that suggested a change in the
volume porosity percentage range in the identifications because the
agency does not believe that a single animal study is sufficient to
demonstrate in vivo performance of joint replacement devices in humans.
FDA also notes that a material with a higher porosity is not
necessarily excluded and that a sponsor of a new device may submit
material characterization information to demonstrate that a more porous
material is substantially equivalent to a legally marketed predicate
device.
FDA disagrees with the comment that suggested that the
identifications should allow for a change to a new material that is
comparable, because this addition to the identifications is
unnecessary. The device identifications do not exclude the use of new
materials in devices whose safety and effectiveness performance can be
demonstrated to be substantially equivalent to legally marketed
devices.
Based on consideration of this comment and reevaluation of
previously cleared orthopedic joint prostheses, FDA has revised the
device identifications published in the notice of panel recommendation.
FDA has determined that the words metal and polymer adequately define
the material composition of the devices and that it is unnecessary to
list in the device identifications all the types of metals and polymers
in legally marketed devices of these types. FDA has also removed the
porous coating characteristics from the device identifications in the
notice of panel recommendation because it is also unnecessary to list
porous coating characteristics ranges in the device identifications.
FDA has concluded that it is more appropriate to describe materials and
porous coating characteristics in the class II special controls
guidance document. FDA notes that guidance documents can be updated
after applicants demonstrate that devices with new materials are
substantially equivalent legally marketed devices.
III. FDA's Conclusion
After reviewing the data in the petition and presented at the Panel
meeting, and after considering the Panel's recommendation and the
comments on the notice of panel recommendation, FDA has determined that
the knee joint patellofemorotibial metal/polymer porous-coated
uncemented prosthesis, which is intended to be implanted to replace a
knee joint, and the knee joint femorotibial (uni-compartmental) metal/
polymer porous-coated uncemented prosthesis, which is intended to be
implanted to replace part of a knee joint, can be reclassified from
class III into class II.
On February 3, 2003, FDA issued an order to the petitioner
reclassifying the devices into class II (special controls). The order
also identified the special control applicable to these devices as a
guidance document entitled ``Class II Special Controls Guidance
Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer
Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.''
The class II special controls guidance document incorporates the 4 FDA
guidance documents and the 11 American Society for Testing Materials
(ASTM) consensus standards that were identified as proposed special
controls for the devices in the notice of panel recommendation. FDA
notes that the class II special controls guidance document includes the
updated ASTM consensus standards. FDA has also incorporated into the
class II special controls guidance document one additional FDA guidance
document, 16 additional ASTM consensus standards, and 11 International
Organization for Standardization (ISO) consensus standards. This class
II special controls guidance document is now the special control for
these devices.
An alternative approach to the special controls guidance document
may be used if such approach satisfies the applicable statute and
regulations. Following the effective date of this final classification
rule, any firm submitting a 510(k) premarket notification for one of
these devices will need to address the issues covered in the special
control guidance. However, the firm need only show that its device
meets the recommendations of the guidance or in some other way provides
equivalent assurances of safety and effectiveness.
Accordingly, as required by 21 CFR 860.134(b)(6) and (b)(7) of the
regulations, FDA is announcing the reclassification of the generic knee
joint patellofemorotibial metal/polymer porous-coated uncemented
prosthesis, which is intended to be implanted to replace a knee joint,
and the knee joint femorotibial (uni-compartmental) metal/polymer
porous-coated uncemented prosthesis, which is intended to be implanted
to replace part of a knee joint, from class III into class II. In
addition, FDA is issuing this final rule to codify the reclassification
of the device by adding new Sec. Sec. 888.3565 and 888.3535.
IV. Electronic Access
In order to receive the guidance document entitled ``Class II
Special Controls Guidance Document: Knee Joint Patellofemorotibial and
Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses;
Guidance for Industry and FDA'' via your fax machine, call the CDRH
Facts-
[[Page 14137]]
On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. Press 1 to enter the system. At the second voice prompt,
press 1 to order the document. Enter the document number 1418 followed
by the pound sign ([numsign]). Follow the remaining prompts to complete
your request.
Persons interested in obtaining a copy of the FDA guidance document
may do so using the Internet. The Center for Devices and Radiological
Health (CDRH) maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer. Updated on a regular basis, the CDRH home page
includes device safety alerts, Federal Register reprints, information
on premarket submissions (including lists of approved applications and
manufacturers' addresses), small manufacturers' assistance, information
on video conferencing and electronic submissions, Mammography Matters,
and other device-oriented information. You may access the CDRH home
page at http://www.fda.gov/cdrh. You may search for all CDRH guidance
page at http://www.fda.gov/cdrh. You may search for all CDRH guidance
documents at http://www.gfa.gov/cdrh/guidance.html. Guidance documents
documents at http://www.gfa.gov/cdrh/guidance.html. Guidance documents
are also available at http://www/fda.gov/ohrms/dockets.
V. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this
reclassification 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.
VI. Analysis of Impacts
FDA has examined the impacts of this final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 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 agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
order and so is not subject to review under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Reclassification of these devices from class III to
class II will relieve all manufacturers of the devices of the cost of
complying with the premarket approval requirements in section 515 of
the act. Because reclassification will reduce regulatory costs with
respect to these devices, it will impose no significant economic impact
on any small entities, and it may permit small potential competitors to
enter the marketplace by lowering their costs. The agency, therefore,
certifies that this final rule will not have a significant economic
impact on a substantial number of small entities. In addition, this
final rule will not impose costs of $110 million or more on either the
private sector or state, local, and tribal governments in the
aggregate, and, therefore, a summary statement or analysis pursuant to
section 202(a) of the Unfunded Mandates Reform Act of 1995 is not
required.
VII. Federalism
FDA has analyzed this final rule in accordance with Executive Order
13132. FDA has determined that the rule does not contain policies that
have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Accordingly, the agency has concluded that this final rule does not
contain policies that have federalism implications as defined in the
order and, consequently, a federalism summary impact statement is not
required.
VIII. Paperwork Reduction Act of 1995
FDA concludes that this final rule contains no new collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (Public Law. 104-13)
is not required.
List of Subjects in 21 CFR Part 888
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 888 is amended as follows:
PART 888--ORTHOPEDIC DEVICES
1. The authority citation for 21 CFR part 888 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 888.1 is amended by adding paragraph (e) to read as
follows:
Sec. 888.1 Scope
* * * * *
(e) Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.
3. Section 888.3535 is added to subpart D to read as follows:
Sec. 888.3535 Knee joint femorotibial (uni-compartmental) metal/
polymer porous-coated uncemented prosthesis.
(a) Identification. A knee joint femorotibial (uni-compartmental)
metal/polymer porous-coated uncemented prosthesis is a device intended
to be implanted to replace part of a knee joint. The device limits
translation and rotation in one or more planes via the geometry of its
articulating surface. It has no linkage across-the-joint. This generic
type of device is designed to achieve biological fixation to bone
without the use of bone cement. This identification includes fixed-
bearing knee prostheses where the ultra-high molecular weight
polyethylene tibial bearing is rigidly secured to the metal tibial
baseplate.
(b) Classification. Class II (special controls). The special
control is FDA's guidance: ``Class II Special Controls Guidance
Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer
Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.''
See Sec. 888.1 for the availability of this guidance.
4. Section 888.3565 is added to subpart D to read as follows:
Sec. 888.3565 Knee joint patellofemorotibial metal/polymer porous-
coated uncemented prosthesis.
(a) Identification. A knee joint patellofemorotibial metal/polymer
porous-coated uncemented prosthesis is a device intended to be
implanted to replace a knee joint. The device limits translation and
rotation in one or more planes via the geometry of its articulating
surfaces. It has no linkage across-the-joint. This generic type of
device is designed to achieve biological fixation to bone without the
use of bone cement. This identification includes fixed-bearing knee
prostheses where the ultra high molecular weight polyethylene tibial
bearing is rigidly secured to the metal tibial base plate.
(b) Classification. Class II (special controls). The special
control is FDA's guidance: ``Class II Special Controls Guidance
Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer
Porous-Coated Uncemented Prostheses; Guidance for
[[Page 14138]]
Industry and FDA.'' See Sec. 888.1 for the availability of this
guidance.
Dated: March 10, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health
[FR Doc. 03-6857 Filed 3-21-03; 8:45 am]
BILLING CODE 4160-01-S