[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)]
[Notices]
[Pages 25594-25595]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6458]


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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://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://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 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