Guidance for Industry on Medical Device Appeals and Complaints: A Guidance on Dispute Resolution; Availability

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.

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

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