[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]



-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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