[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Notices]
[Pages 9569-9570]
From the Federal Register Online via the Government Printing 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