[Federal Register: September 29, 2003 (Volume 68, Number 188)]
[Notices]
[Page 55967-55968]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se03-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
SUPPLEMENTARY INFORMATION:
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
107-250)).
[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]
BILLING CODE 4160-01-S