[Federal Register Volume 70, Number 195 (Tuesday, October 11, 2005)]
[Notices]
[Pages 59074-59075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20329]


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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Draft Guidance for Industry and FDA Staff: Compliance With the 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availability of the draft guidance entitled ``Compliance With Section 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DATES: Submit written or electronic comments on this draft guidance so 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    Submit written comments concerning this draft guidance to the 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