[Federal Register: September 28, 2004 (Volume 69, Number 187)]
[Notices]
[Page 57940-57941]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28se04-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
SUPPLEMENTARY INFORMATION:
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
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 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
and
[[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
advance.
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
ADDRESSES).
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]
BILLING CODE 4160-01-S