[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]
BILLING CODE 4160-01-F