[Federal Register Volume 68, Number 120 (Monday, June 23, 2003)]
[Notices]
[Pages 37161-37162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15731]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03D-0226]
Draft Guidance for Industry and FDA Staff; Compliance With
Section 301 of the Medical Device User Fee and Modernization Act of
2002--Identification of Manufacturer of Medical 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availability of a draft guidance for industry and FDA staff entitled
``Compliance With Section 301 of the Medical Device User Fee and
Modernization Act of 2002--Identification of Manufacturer of Medical
Devices.'' Section 301 of the Medical Device User Fee and Modernization
Act of 2002 (MDUFMA) requires that a device, or an attachment to the
device, bear prominently and conspicuously the name of the
manufacturer, a generally recognized abbreviation of such name, or a
unique and generally recognized symbol that identifies the
manufacturer. Section 301 becomes effective on April 26, 2004, for
devices introduced or delivered for introduction into interstate
commerce after that date. This draft guidance provides that the agency,
in the exercise of enforcement discretion, does not intend to object if
a manufacturer has not yet fully implemented the changes required by
section 301 of MDUFMA for devices introduced or delivered for
introduction into interstate commerce after April 26, 2004, for a
period of up to 18 months after FDA issues final guidance on its
interpretation and implementation of section 301. This draft guidance
is neither final, nor is it in effect at this time.
DATES: Submit written or electronic comments by September 22, 2003.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance entitled ``Compliance With Section 301
of the Medical Device User Fee and Modernization Act of 2002--
Identification of Manufacturer of Medical Devices'' to the Division of
Small Manufacturers, International, and Consumer Assistance (HFZ-220),
Center for Devices and Radiological Health (CDRH), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your
request, or fax your request to 301-443-8818. 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. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the draft guidance.
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, 301-594-4692, or Leonard Wilson,
Center for Biologics Evaluation and Research (HFM-25), Food and Drug
Administration, 8800 Rockville Pike, Bethesda, MD 20892, 301-827-0799.
SUPPLEMENTARY INFORMATION:
I. Background
MDUFMA (Public Law 107-250) added a provision to the Federal Food,
Drug, and Cosmetic Act that requires 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 that identifies the
manufacturer. The requirement may be waived based on a determination
that compliance is not feasible or would compromise the provision of
reasonable assurance of safety and effectiveness for the device.
Failure to comply with the new requirement misbrands the device
(section 301 of MDUFMA (21 U.S.C. 352(u))). This provision is effective
April 26, 2004, with respect to devices introduced or delivered for
introduction into interstate commerce after that date.
This draft guidance provides that, in the exercise of enforcement
discretion, FDA does not intend to object if a manufacturer has not yet
fully implemented the changes required by section 301 of MDUFMA for
devices introduced or delivered for introduction into interstate
commerce after April 26, 2004, the effective date of the provision, for
a period of up to 18 months after FDA issues final guidance on the
implementation of section 301.
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 the
compliance with section 301 of MDUFMA. 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. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the draft
guidance. 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.
[[Page 37162]]
IV. Electronic Access
To receive the draft guidance for industry and FDA staff entitled
``Compliance With Section 301 of the Medical Device User Fee and
Modernization Act of 2002-Identification of Manufacturer of Medical
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
([numsign]). 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. 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.
Dated: June 13, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15731 Filed 6-20-03; 8:45 am]
BILLING CODE 4160-01-S