[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Notices]
[Pages 9569-9570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4842]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Guidance for Industry on Medical Device Appeals and Complaints: A
Guidance on Dispute Resolution; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document entitled ``Medical Device Appeals
and Complaints: A Guidance on Dispute Resolution.'' FDA currently has a
myriad of dispute resolution and regulatory appeal processes that
manufacturers of medical devices and radiological products can avail
themselves of in situations where they disagree with a regulatory
decision or action initiated by the agency. The agency's Center for
Devices and Radiological Health (CDRH) is making this guidance document
available in an effort to clarify these various processes and assist
the industry in determining which process or processes are appropriate
in a given circumstance.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written comments concerning this guidance document to
the contact person listed below. Submit written requests for single
copies of the guidance document entitled ``Medical Device Appeals and
Complaints: A Guidance on Dispute Resolution'' to the Division of Small
Manufacturers Assistance, Center for Devices and Radiological Health
(HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville,
MD 20850. Send two self-addressed adhesive labels to assist that office
in processing your request, or fax your request to 301-443-8818. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance.
FOR FURTHER INFORMATION CONTACT: John F. Stigi, Center for Devices and
Radiological Health (HFZ-220), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-443-7491.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document represents an effort by the agency to
catalogue the various types of processes for seeking and achieving
resolution of disputes that arise between manufacturers of medical
devices and radiological products and components of FDA that are
involved in clinical, scientific, and regulatory decisionmaking that
affects these industries. Although this guidance document does not
advocate one process over another, it intends to: (1) Explain the
dispute resolution processes that exist by virtue of Federal law,
agency regulations, and administrative practices; and (2) provide
general guidance on which processes are most suited for particular
situations. In addition, the guidance document offers practical, easy-
to-use information on how and where to file requests for
reconsideration of agency actions and decisions, as well as requests
for dispute resolution, and gives useful information that sets forth
the variety of FDA and Department of Health and Human Services
components that are responsible for reviewing, investigating, and
resolving disputes and external complaints. Because dispute resolution
processes for medical devices and radiological products and the agency
components charged to administer them will likely undergo change over
time, this guidance document is subject to periodic revision. For
example, the recently enacted Food and Drug Administration
Modernization Act of 1997 mandates the agency to establish discrete
processes for the resolution of disputes related to the regulation of
medical devices. The guidance document lays the groundwork for new
agency procedures which, in the coming months, will be articulated in
more detail and incorporated into the document.
[[Page 9570]]
This is a level 2 guidance document under FDA's Good Guidance
Practices policy. This guidance document does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the applicable statute, regulations, or both.
II. Electronic Access
In order to receive the ``Medical Device Appeals and Complaints: A
Guidance On Dispute Resolution'' guidance document via your fax
machine, call the CDRH Facts-on-Demand (FOD) system at 800-899-0381 or
301-827-0111 from a touch-tone telephone. At the first voice prompt,
press 1 to access DSMA Facts, at the second voice prompt press 2, and
then enter the document number (396) followed by the pound sign (#).
Then follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance document may
also do so by using the World Wide Web (WWW). CDRH maintains an entry
on the WWW for easy access to information including text, graphics, and
files that may be downloaded to a PC with access to the Web. The CDRH
home page is updated on a regular basis and includes the ``Medical
Device Appeals and Complaints: A Guidance On Dispute Resolution''
guidance document, device safety alerts, Federal Register reprints,
information on premarket submissions (including lists of approved
applications and manufacturers' addresses), small manufacturers'
assistance, information on video conferencing and electronic
submissions, mammography matters, and other device-oriented
information. The CDRH home page may be accessed at http://www.fda.gov/
cdrh. ``Medical Device Appeals and Complaints: A Guidance On Dispute
Resolution'' is also available on the medical device reporting page at
http://www.fda.gov/cdrh/modact/modern.html.
A text-only version of the CDRH Web site is also available from a
computer or VT-100 compatible terminal by dialing 800-222-0185
(terminal settings are 8/1/N). Once the modem answers, press Enter
several times and then select menu choice 1: FDA BULLETIN BOARD
SERVICE. From there, follow instructions for logging in, and at the BBS
TOPICS PAGE, arrow down to the FDA home page (do not select the first
CDRH entry). Then select Medical Devices and Radiological Health. From
there, select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general
information, or arrow down for specific topics.
III. Request for Comments
Interested persons, may at any time, submit to the contact person
listed above written comments regarding this guidance document.
Comments will be considered in determining whether to revise or revoke
the guidance.
Dated: February 11, 1998.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-4842 Filed 2-20-98; 4:00 pm]
BILLING CODE 4160-01-F