[Federal Register Volume 62, Number 167 (Thursday, August 28, 1997)]
[Notices]
[Pages 45668-45669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0298]


Distributor Medical Device Reporting; Draft Compliance Policy 
Guide; 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 draft Compliance Policy Guide (CPG) entitled 
``Distributor Medical Device Reporting.'' The purpose of the CPG is to 
provide guidance concerning the interpretation and applicability of 
some of the provisions in the Medical Device Distributor Reporting 
Regulation. FDA believes that the following guidance will improve the 
administration and efficiency of medical device distributor reporting 
as well as the quality of information received.

DATES: Written comments on the draft CPG may be submitted by November 
26, 1997.

ADDRESSES: Submit written requests for single copies of the draft CPG 
to the Division of Small Manufacturers Assistance (DSMA), Center for 
Devices and Radiological Health (CDRH) (HFZ-220), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597 or 
outside MD 1-800-638-2041. Send two self-addressed adhesive labels to 
assist that office in processing your requests, or FAX your request to 
301-443-8818. Facsimiles of the draft CPG are available from DSMA. To 
receive the draft CPG on your fax machine, call the CDRH Facts-On-
Demand system at 1-800-899-0381 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, ``120'' followed by the pound sign, ``#''. Follow the remaining 
voice prompts to complete the request. Submit written comments on the 
draft CPG to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Chester T. Reynolds, Office of 
Compliance (HFZ-300), Center for Devices and Radiological Health, Food 
and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-
594-4618, ext. 114.
SUPPLEMENTARY INFORMATION:

I. Background

    Distributors of devices have been required, by statute, to report 
device related deaths, serious illnesses, serious injuries and 
malfunctions to FDA and the manufacturers of the devices since May 28, 
1992. The regulations that implemented the statutory provisions can be 
found in parts 804 and 807 (21 CFR parts 804 and 807).
    Since 1993, FDA has received thousands of Medical Device Reports 
(MDR's) submitted in response to part 804. As a result of this 
experience, FDA has developed a draft CPG to provide guidance 
concerning the interpretation and applicability of some of the 
provisions of the Distributor Medical Device Reporting Regulation. For 
practical purposes, FDA intends to interpret the reporting standards 
for both domestic distributors and importers to be the same. In 
exercising its enforcement discretion, the agency does not plan to 
initiate regulatory action involving distributor requirements for staff 
training and education. Additionally, FDA encourages distributors to 
voluntarily use the reporting form MEDWATCH FDA Form 3500A. The agency 
believes that using this form will reduce the paperwork and level of 
effort for distributors, manufacturers, and FDA. This draft guidance 
document represents the agency's current thinking on distributor 
medical device reporting. 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. Request for Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft

[[Page 45669]]

CPG entitled ``Distributor Medical Device Reporting.'' Two copies of 
any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The agency will review all 
comments, but in issuing a final CPG, need not specifically address 
every comment. The agency will make changes to the CPG in response to 
comments, as appropriate. A copy of the draft CPG and received comments 
may be seen in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Copies of the draft CPG may also be downloaded to a personal 
computer with access to the World Wide Web (www). The Office of 
Regulatory Affairs (ORA) and CDRH Home Pages include the draft CPG and 
may be accessed at ``http://www.fda.gov/ora'' or ``http://www.fda.gov/
cdrh'' respectively. The draft CPG will be available on the Compliance 
References or Compliance Information pages for ORA and CDRH 
respectively.

    Dated: August 15, 1997.
Gary Dykstra,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 97-22702 Filed 8-27-97; 8:45 am]
BILLING CODE 4160-01-F