[Federal Register: May 1, 2006 (Volume 71, Number 83)]
[Notices]
[Page 25594-25595]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01my06-60]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0401]
Guidance for Industry and Food and Drug Administration Staff:
Compliance With the Medical Device User Fee and Modernization Act of
2002, as amended--Prominent and Conspicuous Mark of Manufacturers on
Single-Use Devices; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Compliance With Section 301 of
the Medical Device User Fee and Modernization Act of 2002, as amended--
Prominent and Conspicuous Mark of Manufacturers on Single-Use
Devices.'' The Medical Device User Fee and Modernization Act 2002
(MDUFMA), as amended by the Medical Device User Fee Stabilization Act
of 2005 (MDUFSA), requires that FDA issue guidance identifying the
circumstances in which the name, abbreviation, or symbol of the
manufacturer of an original device is not ``prominent and
conspicuous.'' MDUFSA requires that FDA issue guidance no later than
180 days after the date of enactment (August 1, 2005).
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Compliance With Section
301 of the Medical Device User Fee and Modernization Act of 2002, as
amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use
Devices'' to the Division of Small Manufacturers, International, and
Consumer Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-443-8818. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Center for Devices
and Radiological Health (HFZ-300), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0106.
SUPPLEMENTARY INFORMATION:
I. Background
MDUFMA (Public Law 107-250) amended section 502 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352) to require a
device, or an attachment to the device, to bear prominently and
conspicuously the name of the manufacturer, a generally recognized
abbreviation of such name, or a unique and generally recognized symbol
identifying the manufacturer. This labeling provision applied to all
devices and all device manufacturers.
On August 1, 2005, MDUFSA (Public Law 109-43) amended section
502(u) of the act by limiting the provision to reprocessed single-use
devices (SUDs) and the manufacturers who reprocess them. Therefore,
section 502(u) of the act, as amended by MDUFSA, no longer sets forth
requirements for original equipment manufacturers, unless they also
reprocess SUDs. Under the amended provision, if an original device or
an attachment to it does not prominently and conspicuously bear the
name of the manufacturer of the original device, a generally recognized
abbreviation of such name, or a unique and generally recognized symbol
identifying such manufacturer, the manufacturer who reprocesses the SUD
may identify itself using a detachable label on the packaging of the
device.
Section 2(c)(2) of MDUFSA requires that FDA issue guidance not
later than 180 days after the date of its enactment to identify the
circumstances under which the identifying mark of a manufacturer of an
original device is not ``prominent and conspicuous,'' as used in
section 502(u) of the act. On October 11, 2005, FDA issued draft
guidance describing the circumstances under which the agency would not
consider a manufacturer's mark to be prominent and conspicuous. FDA
received several comments on the draft guidance, all of which were
considered in finalizing the guidance.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on ``Compliance With Section 301 of the
Medical Device User Fee and Modernization Act of 2002, as amended--
Prominent and Conspicuous Mark of Manufacturers on Single-Use
Devices.'' It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
To receive `` Compliance With Section 301 of the Medical Device
User Fee and Modernization Act of 2002, as amended--Prominent and
Conspicuous Mark of Manufacturers on Single-Use Devices'' by fax, call
the CDRH Facts-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 a document. Enter the document number (1217)
followed by the pound sign (). Follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. 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 with Internet access. Updated on a
regular basis, the CDRH home page includes device safety alerts,
[[Page 25595]]
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturer's assistance, information on video
conferencing and electronic submissions, Mammography Matters, and other
device-oriented information. The CDRH web site may be accessed at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The collection(s) of information in this guidance were approved under
OMB control number 0910-0577.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Comments received may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: April 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6458 Filed 4-28-06; 8:45 am]
BILLING CODE 4160-01-S