[Federal Register: October 11, 2005 (Volume 70, Number 195)]
[Notices]
[Page 59074-59075]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11oc05-62]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0401]
Draft Guidance for Industry and FDA Staff: Compliance With the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availability of the draft guidance entitled ``Compliance With Section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 of 2002
(MDUFMA), as amended by the Medical Device User Fee Stabilization Act
of 2005 (MDUFSA), requires that FDA issue guidance within 180 days of
enactment (August 1, 2005) identifying the circumstances in which the
name, abbreviation, or symbol identifying the manufacturer of an
original device is not ``prominent and conspicuous.''
DATES: Submit written or electronic comments on this draft guidance so
that they are received by close of business on November 10, 2005. FDA
will not be able to consider comments received after that date in
developing the final guidance. FDA may consider late comments at a
future time if the
[[Page 59075]]
guidance needs to be revised at a later date.
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Submit written comments concerning this draft guidance to the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://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, including reprocessors.
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. When finalized, this guidance document will
satisfy this MDUFSA requirement. As stated previously, FDA requests
that interested person submit their comments on the draft guidance
within 30 days of its publication. FDA will consider these comments to
determine whether to revise the guidance before issuing it in final
form.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized will represent 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
machine, 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 draft guidance may
also do so by 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 with Internet access. 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 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://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In the Federal
Register of September 29, 2005 (70 FR 56910), FDA published a 60-day
notice soliciting comments on the information collection provisions
contained in this guidance.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this draft
guidance. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
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. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20329 Filed 10-7-05; 8:45 am]
BILLING CODE 4160-01-S