[Federal Register Volume 62, Number 138 (Friday, July 18, 1997)]
[Notices]
[Pages 38567-38568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18918]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96D-0137]


Medical Device Reporting, Guidance Document for Manufacturers; 
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 Reporting 
(MDR) for Manufacturers.'' The guidance describes the new medical 
device reporting requirements for manufacturers, and it is intended for 
both domestic and foreign medical device manufacturers. The MDR 
regulations provide a mechanism for FDA to identify and monitor 
significant adverse events involving medical devices so that problems 
may be detected and corrected in a timely manner.
ADDRESSES: Submit written requests for single copies of the ``Medical 
Device Reporting (MDR) for Manufacturers'' guidance document 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 requests, or fax your 
request to 301-443-8818. Requestors will be sent a floppy diskette with 
a Microsoft Word document file containing the guidance document. See 
the Supplementary Information section for electronic access to the 
draft guidance.

FOR FURTHER INFORMATION CONTACT: Bryan H. Benesch, Center for Devices 
and Radiological Health, HFZ-220, 1350 Piccard Dr., Rockville, MD 
20850, 301-443-7491, ext. 131.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 31, 1996 (61 FR 27361), FDA 
announced the availability of a draft guidance entitled ``Medical 
Device Reporting for Manufacturers.'' The guidance document contained 
information to help manufacturers comply with the new MDR regulations. 
The purpose of the guidance document was to: (1) Provide domestic and 
foreign manufacturers with a thorough description of the current MDR 
regulations; (2) give a clear

[[Page 38568]]

understanding of their reporting responsibilities and guidance to aid 
in the completion of the MDR forms; (3) give an overview of required 
written MDR procedures, records and files; and (4) supply information 
on sources for forms, instructions, and other MDR information.
    Comments were requested and the guidance has been revised. FDA 
addressed the changes mandated by the Safe Medical Devices Act and the 
Medical Device Amendments of 1992.
    ``Medical Device Reporting (MDR) for Manufacturers'' represents the 
agency's current thinking on medical device reporting for 
manufacturers. It 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 requirements of the 
applicable statute, regulations, or both.

II. Electronic Access

    In order to receive the ``Medical Device Reporting (MDR) for 
Manufacturers'' 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 987 followed by the pound sign (). Then 
follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may do so by 
using the World Wide Web (WWW). The Center for Devices and Radiological 
Health (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 Reporting (MDR) for 
Manufacturers'' 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 Reporting for Manufacturers'' is available on 
the medical device reporting page at: http://www.fda.gov/cdrh/mdr.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.

    Dated: June 13, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-18918 Filed 7-17-97; 8:45 am]
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