[Federal Register: September 28, 2004 (Volume 69, Number 187)]
[Page 57940-57941]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0423]

Second Annual Stakeholder Meeting on the Implementation of the 
Medical Device User Fee and Modernization Act of 2002 Provisions; 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public meeting: Second Annual Stakeholder Meeting on the 
Implementation of the Medical Device User Fee and Modernization Act of 
2002 (MDUFMA). The topic of discussion is the agency's progress in 
implementing the various MDUFMA provisions, including the guidances FDA 
has issued on the new law.

DATES: The public meeting will be held on November 18, 2004, from 9 
a.m. to 5 p.m. Registration is required by Friday, October 22, 2004. 
All individuals wishing to make a presentation or to speak on an issue 
should indicate their intent and the topic to be addressed and provide 
an abstract of the topic to be presented by October 22, 2004. Time for 
presentations will be limited to 10 minutes.

ADDRESSES: The public meeting will be held at the Marriott Gaithersburg 
Washingtonian Center, 9751 Washingtonian Blvd., Gaithersburg, MD.
    Submit written requests to make an oral presentation to Cindy 
Garris, Center for Devices and Radiological Health (HFZ-220), Food and 
Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-
6597, ext. 121, FAX: 301-443-8818, e-mail: cxg@cdrh.fda.gov. Include 
your name, title, firm name, address, telephone, and fax number with 
your request. All requests and presentation materials should include 
the docket number found in brackets in the heading of this document. 
Submit all request for suggestions and recommendations to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cindy Garris, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-443-6597, ext. 121, FAX: 301-443-
8818, e-mail: cxg@cdrh.fda.gov.


I. Background

    On October 26, 2002, MDUFMA amended the Federal Food, Drug, and 
Cosmetic Act to include several new significant provisions. MDUFMA 
authorizes the following provisions: (1) User fees for certain 
premarket applications, (2) establishment of good manufacturing 
practice (GMP) inspections by FDA-accredited persons (third-parties), 
and (3) new requirements for reprocessed single-use devices. In 
addition, the new law contains several provisions that, while narrower 
in scope than the previously mentioned provisions, are significant 
changes to the device law. These include a modular review program for 
premarket approval applications (PMAs), electronic labeling for certain 
prescription devices, several provisions concerning devices for 
pediatric use, and a new labeling requirement that requires the 
manufacturer's name to appear on the device itself, with certain 
    The agency has been working to implement the new law since its 
passage in October 2002. During this time, FDA has accomplished the 
following significant milestones: (1) Established a user fee program 
with payment, billing, and appeals procedures; (2) published 
accreditation criteria for persons conducting third-party inspections 
and accredited 15 such persons; (3) identified certain reprocessed 
single-use devices that will be subject to additional marketing 
requirements; and (4) published guidances related to the PMA, premarket 
notification (510(k)), and biologics license application (BLA) 
programs, bundling multiple devices in a single application, and 
premarket review of pediatric devices. The agency is drafting 
additional documents to be issued in the near future.

II. Agenda

    On November 18, 2004, FDA is providing the opportunity for all 
interested persons to provide information and share their views on the 
implementation of MDUFMA. The following topics will be discussed:
     User Fees Process--This panel will consider the small 
business determination and the user fee payment processes.
    Premarket Review Performance Goals--This panel will discuss the 
agency's progress in meeting the PMA, 510(k), and BLA review 
performance goals.
     Qualitative Performance Goals (e.g., Modular PMA and GMP 

[[Page 57941]]

Bioresearch Monitoring (BIMO) Inspection Programs)-- This panel will 
discuss the agency's progress in developing various qualitative 
performance goals, such as those related to the modular PMA and GMP 
inspection programs. This panel will also discuss internally-
established milestones for the BIMO inspection process.
     Third-Party Inspection Program--This panel will discuss 
implementing guidances for the program, including establishment 
eligibility criteria for inspection by a third party.
     Reuse-- This panel will discuss the FDA-identified 
reprocessed single-use devices that require submission of certain 
validation data and the guidance that describes the agency's review 
procedures for such submissions. This panel will also report on FDA's 
progress in reviewing the validation data submissions.
    At the conclusion of the meeting, there will be a general 
discussion from the floor.

III. Registration

    Online registration for the meeting is required by October 22, 
2004. Acceptance will be on a first-come, first-served basis. There 
will be no onsite registration. Please register online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/meetings/120303.html.
 FDA is pleased to provide the 

opportunity for interested persons to listen from a remote location to 
the live proceedings of the meeting. In order to ensure that a 
sufficient number of call-in lines are available, please register to 
listen to the meeting at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/meetings/120303.html 

by October 22, 2004. Persons without Internet access may register for 
the onsite meeting or to listen remotely by calling 301-443-6597, ext. 
121 by October 22, 2004.
    If you need special accommodations due to a disability, please 
contact Cindy Garris at 301-443-6597, ext. 121 at least 7 days in 

IV. Request for Suggestions, Recommendations, and Materials

    FDA is particularly interested in receiving suggestions from 
stakeholders on other topics for discussion. The agency is interested 
in receiving recommendations about other provisions yet to be 
implemented both in terms of their priority for implementation and 
specifics on the implementation itself. Send suggestions or 
recommendations to the Division of Dockets Management (see ADDRESSES).
    FDA will place an additional copy of any material it receives on 
the docket for this document (2004N-0423). Suggestions, 
recommendations, and materials may be seen at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday (see 

V. Transcripts

    Following the meeting, transcripts will be available for review at 
the Division of Dockets Management (see ADDRESSES).

    Dated: September 22, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-21676 Filed 9-27-04; 8:45 am]