[Federal Register: September 29, 2003 (Volume 68, Number 188)]
[Page 55967-55968]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0422]

Annual Stakeholder Meeting on the Implementation of the Medical 
Device User Fee 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: 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 meeting will be held on December 3, 2003, from 9 a.m. to 5 
p.m. at the Gaithersburg Hilton Hotel, 690 Perry Pkwy., Gaithersburg, 
MD 20877. Registration is required by November 3, 2003. All individuals 
wishing to make a presentation or to speak on an issue also must 
indicate their intent and the topic to be addressed and provide an 
abstract of the topic to be presented by November 3, 2003. Time for 
presentations will be limited to 10 minutes.

ADDRESSES: Send written requests to make a 10-minute oral presentation 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Send 
electronic requests to make a 10-minute oral presentation to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Include your name, title, firm name, 
address, telephone, and fax number with your request. All requests and 
presentation materials must include the docket number found in brackets 
in the heading of this document. Submit all requests and presentation 
materials by November 3, 2003.

FOR FURTHER INFORMATION CONTACT: Sherrie Appel, Center for Devices and 
Radiological Health (HFZ-200), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-443-2845, FAX: 301-443-8810, e-mail: saa@cdrh.fda.gov.


I. Background

    On October 26, 2002, MDUFMA amended the Federal Food, Drug, and

[[Page 55968]]

Cosmetic Act to include several new significant provisions. MDUFMA 
authorizes the following provisions: (1) User fees for certain 
premarket applications, (2) establishment 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 exceptions.
    The agency has been working to implement the new law since its 
passage in October 2002. During this time, FDA has accomplished the 
following milestones: Established a user fee program with payment, 
billing, and appeals procedures; met statutory timeframes for the 
release of the accreditation criteria for persons conducting third-
party inspections and the identification of certain reprocessed single-
use devices that will be subject to additional premarket requirements; 
and published several guidances, such as those related to PMA 
supplement definitions and bundling of multiple devices in a single 
application. The agency is drafting other documents to be issued in the 
near future.
    Agenda: On December 3, 2003, FDA is providing the opportunity for 
all interested persons to provide information and share their views on 
the implementation of MDUFMA. The agenda will consist of the following 
panel sessions that will include panelists from FDA, industry, and 
other stakeholders:
    [sbull] Panel 1: How is the User Fees Process Working? This panel 
will consider the small business determinations and the user fee 
process and performance goals.
    [sbull] Panel 2: Electronic Labeling and Identification of the 
Manufacturer on the Device. This panel will address electronic labeling 
for prescription devices intended for use in healthcare facilities 
(section 206 of MUDFMA (Public Law 107-250)) and identification of the 
manufacturer on the device itself (section 301 of MDUFMA (Public Law 
    [sbull] Panel 3: Bundling, Modular PMA, and Expedited PMAs. This 
panel will discuss guidances that address various PMA issues, including 
definitions of supplements, modular review, bundling multiple devices/
indications for use in a single application, and clinical studies of 
pediatric devices.
    [sbull] Panel 4: Third-Party Inspection Program. This panel will 
discuss implementation of the program, including eligibility criteria 
for use of a third party by a manufacturer.
    [sbull] Panel 5: Reuse. This panel will discuss FDA-identified 
reprocessed single-use devices that will require premarket submission 
of validation data and the associated guidance for submission of data.
    [sbull] General Discussion Period From the Floor: At the conclusion 
of the panels, there will be a general discussion from the floor.
    Also at this time, FDA is particularly interested in receiving 
comments 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.
    FDA will place an additional copy of any material it receives on 
the docket for this document (2003N-0422). Comments and materials may 
be seen at the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday (see ADDRESSES).
    Registration: Online registration for the meeting is required by 
November 3, 2003. 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 November 3, 2003. Persons without Internet access may register for 
the onsite meeting or to listen remotely by calling 301-443-2845 by 
November 3, 2003.
    If you need special accommodations due to a disability, please 
contact Sherrie Appel at 301-443-2845 at least 7 days in advance.
    Transcripts: Following the meeting, transcripts will be available 
for review at the Division of Dockets Management (see ADDRESSES).

    Dated: September 22, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-24494 Filed 9-26-03; 8:45 am]