[Federal Register Volume 62, Number 71 (Monday, April 14, 1997)]
[Notices]
[Page 18137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9528]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of the Committee: Device Good Manufacturing Practice Advisory
Committee.
General Function of the Commitee: To provide advice and
recommendations to the agency on FDA regulatory issues.
Date and Time: The meeting will be held on April 29, 1997, 8:30
a.m. to 5 p.m.
Location: Parklawn Bldg., Conference room D, 5600 Fishers Lane,
Rockville, MD.
Contact Person: Sharon M. Kalokerinos, Center for Devices and
Radiological Health (HFZ-331), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4613, ext. 139, or FDA
Advisory Committee Information line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12398. Please call the Information Line
for up-to-date information on this meeting.
Agenda: The committee will consider a proposed plan developed by
the Center for Devices and Radiological Health (CDRH) to introduce a
risk-based planning model for determining where headquarters and field
enforcement resources should be focused. The model to be presented
calls for greater emphasis on those products that present the greatest
risk to public health, based on such factors as device classification
(Class III and Class II/Tier 3 products), current knowledge of product
performance, and information from the recall and medical device
reporting (MDR) adverse event data bases. Those products that present
minimal risk (Class I and some Class II) would receive less oversight.
Areas being considered for increased coverage include premarket
approval inspections (Class III products), inspections deemed necessary
to address a risk to public health (for cause), followup to violative
inspections, and inspections of devices identified by the risk-based
model.
There are two aspects to this planning model: (1) The
identification of top priority devices which would receive a more
indepth evaluation in terms of causes associated with failures and
malfunctions reported in the data bases; and (2) the utilization of
risk criteria such as the classification and tiering of devices to
determine the parameters of routine good manufacturing practice (GMP)
surveillance, both the frequency and depth of inspectional coverage.
Data used to identify top priority devices would undergo a quality
control evaluation to determine the basis for the large numbers of
reports in the data systems. For example, the recall information would
be evaluated to assure that inclusion on the list is based on
substantive causes of the recall and not on isolated events. Likewise,
MDR information would be evaluated for public health risk versus
reporting artifacts. Scientific implications of failures/malfunctions
would form the basis of the investigational assignments issued, and
CDRH staff would analyze the data collected for commonalities and
trends. Resolution of issues noted may vary depending upon the nature
of the problems. Options include technical and scientific discussions,
training initiatives by FDA or industry, or compliance followup
activities.
The plan proposes a tiered approach to conducting routine GMP
surveillance inspections. Devices carrying a higher risk for the
patient such as Class III and Class II/Tier 3 would be inspected more
frequently. These higher risk devices will also receive comprehensive
inspectional coverage and limited inspections will be conducted for the
lower classifications and tiers.
Procedure: The meeting is open to the public. Interested persons
may present data, information, or views, orally or in writing, on
issues pending before the committee. Written submissions may be made to
the contact person by April 22, 1997. Those desiring to make formal
presentations should notify the contact person, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the aproximate time requested to make their presentation.
Notice of this meeting is given under the Federal Advisory Committe
Act (5 U.S.C. app. 2).
A limited number of overnight accommodations have been reserved at
the DoubleTree Hotel. Attendees requiring overnight accommodations may
contact the hotel at 301-468-1100 and reference the FDA Device Good
Manufacturing Practice Advisory Committee meeting block. Reservations
will be confirmed at the group rate based on availability. Attendees
with a disability requiring special accommodations should contact
Christie Wyatt, KRA Corp., 301-495-1591, ext. 224. The availability of
appropriate accommodations cannot be assured unless prior written
notification is received.
Dated: April 8, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-9528 Filed 4-11-97; 8:45 am]
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