[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Draft Guidance for Industry and FDA Staff; Compliance With 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availability of a draft guidance for industry and FDA staff entitled 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 This draft guidance provides that the agency, 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 This draft guidance 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diskette of the draft guidance entitled ``Compliance With Section 301 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