[Federal Register Volume 60, Number 105 (Thursday, June 1, 1995)]
[Notices]
[Pages 28618-28619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13294]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0124]
Medical Devices; Third Party Review of Selected Premarket
Notifications; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop to discuss a proposed pilot program for third party review of
selected premarket notifications. The purpose of the workshop is to
provide information on the pilot program and to obtain public comments
and suggestions that may help FDA refine its plans for third party
review of selected premarket notifications. This workshop is one aspect
of FDA's efforts in pursuit of the reinventing Government goals of the
National Performance Review as well as the promotion and protection of
the public health.
DATES: The workshop will be held on June 19, 1995, from 9 a.m. to 4:30
p.m. Submit written notices of participation by June 9, 1995.
Participants and other persons who want to be heard must be present by
9 a.m. Submit written comments by July 7, 1995. There is no
registration fee for this workshop. Interested persons are encouraged
to register early because space is limited.
ADDRESSES: The workshop will be held at the Doubletree Hotel Rockville
(formerly, the Holiday Inn Crowne Plaza), 1750 Rockville Pike,
Rockville, MD. A limited number of overnight accommodations have been
reserved at the Doubletree Hotel Rockville. Attendees requiring
overnight accommodations may contact the hotel at 301-468-1100 and
reference FDA meeting group GVL. Reservations will be confirmed at the
group rate based on availability.
A registration form for the workshop may be obtained by contacting
Sociometrics, Inc., 8300 Colesville Rd., Suite 550, Silver Spring, MD
20910, 301-608-2151 or 1-800-729-0890 (FAX 301-608-3542). Persons with
disabilities who require special assistance to attend or participate in
the workshop can be accommodated if advance notification is provided.
If you have a disability that affects your attendance at, or
participation in, this meeting, please contact Ed Rugenstein,
Sociometrics, Inc., in writing and identify your needs. The
availability of appropriate accommodations cannot be assured unless
prior written notification is provided.
Written comments regarding the pilot program may be submitted to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. Those persons who
wish to make a presentation must submit a written notice of
participation to the Dockets Management Branch (address above),
identified with the docket number found in brackets in the heading of
this document, including their name, address, telephone number,
business affiliation, a brief summary of the presentation, and an
estimate of the amount of time required to make their comments. FDA
requests that individuals or groups having similar interests
consolidate their comments and present them through a single
representative. FDA may require joint presentations by persons with
common interests.
Transcripts of the workshop will be available from the Freedom of
Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-443-6310 or FAX 301-443-1726.
FOR FURTHER INFORMATION CONTACT: Eric J. Rechen, Center for Devices
and Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186, FAX 301-594-2977.
SUPPLEMENTARY INFORMATION:
I. Background
On April 6, 1995, FDA announced a limited pilot program to test the
usefulness and practicality of third party review of medical devices.
Under the proposed pilot, FDA will designate private sector
organizations to review premarket notifications under section 510(k) of
the Federal Food, Drug, and Cosmetic Act (the act) (hereinafter
referred to as 510(k)'s). This initiative will provide an alternative
to FDA review and is one aspect of FDA's efforts in pursuit of the
reinventing Government goals of the National Performance Review. FDA
expects the pilot program will begin early in fiscal year 1996.
FDA's primary concern remains the promotion and protection of the
public health. The proposed pilot will include checks and balances to
ensure a high level of quality in the review of 510(k)'s.
II. Outline of the Proposed Third Party Review Pilot
At this time, FDA has not determined the final form of its pilot
third party review process. The initial pilot program will be
restricted to third party review, but not clearance, of 510(k)'s.
During the pilot, the third party will make a recommendation to FDA.
FDA will then make a decision based on the third party's documented
review. The purpose of the pilot is to test the feasibility of third
party review, including the willingness of qualified third parties to
participate, and the quality and timeliness of third party reviews.
Industry participation in the pilot program will be voluntary. An
applicant who does not wish to participate will be able to continue to
submit 510(k)'s to FDA. The pilot will last 2 years, and will be
evaluated by FDA in the second year.
FDA anticipates that the pilot program will be limited to FDA-
designated class I and II devices that involve low-to-moderate risk.
The pilot [[Page 28619]] will exclude 510(k)'s that require clinical
data for a decision. Clear review criteria must also be available, in
the form of FDA guidance documents, consensus standards, or other
appropriate assessment tools. FDA has prepared a preliminary list of
devices that may be included in the pilot (see section IV. of this
document for information on obtaining a copy).
Third party review organizations will be individually accepted by
FDA. FDA will establish and apply requirements covering personnel
qualifications as well as controls over potential conflicts of
interest. FDA believes it is essential that third party review
organizations maintain adequate independence from the device industry.
FDA is also considering additional safeguards to ensure the quality and
impartiality of third party reviews. Among the safeguards being
considered are: FDA examination, acceptance, and oversight of third
party review organizations; provision of training and standard
operation procedures for third parties; audits of third party reviews;
having FDA personnel serve as on site advisors to third party review
bodies; and database checks to track ongoing reviews.
FDA expects that applicants who submit a 510(k) to a third party
during the pilot will pay a fee directly to the third party. FDA does
not expect to take part in setting fees, but rather intends to leave
this to be negotiated between the third party review organization and
the applicant.
The full range of general controls (current good manufacturing
practices (CGMP's), medical device reporting, prohibition against
adulteration and misbranding, etc.) and, where appropriate, special
controls (device tracking, postmarket surveillance, etc.) will be
applicable to devices included in the pilot program.
III. Purpose and Tentative Agenda of the Workshop
The purpose of the workshop is to obtain public comments and
suggestions that will help FDA refine its plans for a pilot program for
third party review of selected 510(k)'s.
Joseph A. Levitt, Deputy Director for Regulations and Policy,
Center for Devices and Radiological Health, FDA, will preside. Mr.
Levitt will be assisted by other FDA officials.
FDA will open the workshop with a summary of the framework for the
proposed pilot program. This presentation will provide information on
the impetus, objectives, and scope of the proposed pilot program.
Following FDA's presentation, other participants will make
presentations. After reviewing the notices of participation, FDA will
allocate the time available for presentations among those persons who
properly file a written notice of participation. FDA will schedule each
appearance and will notify each participant by mail or telephone of the
time allotted to him or her and the approximate time his or her
presentation is scheduled to begin. The full schedule will be available
at the workshop and will subsequently be placed on file in the Dockets
Management Branch under the docket number found in brackets in the
heading of this document. Time permitting, the workshop will also
include an opportunity for interested persons who did not submit a
notice of participation to make brief statements or comments. The
workshop will then proceed to a panel discussion of specific issues
that FDA must resolve before third party reviews of 510(k)'s can begin.
Among the topics to be discussed are the following: Which devices
should be eligible for third party review; criteria for selection or
acceptance of private sector organizations to perform reviews,
including conflict of interest protections; safeguards necessary to
ensure a fair and impartial review by a third party; and funding of
third party reviews.
FDA is making available a list of specific topics for written
comment and discussion at the workshop. (See section IV. of this
document for information on how to obtain a copy.)
The workshop is informal, and the rules of evidence will not apply.
No participant may interrupt the presentation of another participant.
Only the presiding officer and panel members may question participants
at the conclusion of their presentations.
IV. Obtaining Additional Information on the Workshop
Information on the June 19, 1995, workshop, including a more
detailed listing of the topics and issues on which FDA is inviting
comment and a list of the devices proposed for inclusion in the pilot,
can be obtained from the Dockets Management Branch (address above) or
by calling FDAs Facts-on-Demand system. The Facts-on-Demand system can
be reached by calling 1-800-899-0381 or 301-827-0111 on a touch-tone
phone. Follow the instructions provided, and request DSMA shelf number
150. The requested materials will be sent by FAX.
Dated: May 25, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-13294 Filed 5-26-95; 10:22 am]
BILLING CODE 4160-01-F
