[Federal Register Volume 61, Number 106 (Friday, May 31, 1996)]
[Notices]
[Pages 27361-27362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13665]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96D-0137]


Medical Device Reporting, Draft Guidance Document for 
Manufacturers; Notice of 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availability of a draft guidance entitled ``Medical Device Reporting 
for Manufacturers.'' This guidance contains information to help 
facilitate manufacturer compliance with the new Medical Device 
Reporting (MDR) regulation. FDA is inviting comments on the draft 
guidance, particularly on matters not already addressed in the draft 
manufacturer device reporting guidance.

DATES: Submit written comments by August 29, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Comments should be identified by title and the 
docket number found in brackets in the heading of this document. A copy 
of the draft guidance document and received comments are

[[Page 27362]]

available for public examination in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.
    Persons interested in obtaining a copy of the draft guidance 
document may do so by using the World Wide Web. FDA's home page address 
may be accessed at http://www.fda.gov and then select the Medical 
Devices and Radiological Health option. Next, select the Program Areas 
option and then select Medical Device Reporting. All Relevant documents 
will be listed and available for downloading.
    Anyone with a video terminal or personal computer with a modem can 
obtain the draft guidance document from the electronic docket 
administered by the Division of Small Manufacturers Assistance (1-800-
252-1366 or 1-301-594-2741) by making the following menu choices: 5-
Postmarket Surveillance; 2-Medical Device Reports--Policies/Guidelines.
    Individuals unable to use the above two options may request 
information, through the CDRH Facts-on-Demand system, about obtaining 
paper copies of the document, by dialing 1-800-899-0381 or 1-301-827-
0111. After following the voice prompts, request document number 799. 
FDA has arranged to have other government, industry, and health care 
organizations provide paper copies of the document for a fee that each 
organization will set for itself.
FOR FURTHER INFORMATION CONTACT: Earl W. Robinson, Center for Devices 
and Radiological Health (HFZ-530), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-2735.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Safe Medical Devices Act of 1990 (Pub. L. 101-629) 
(SMDA), on November 26, 1991 (56 FR 60024), FDA issued a tentative 
final rule proposing to implement regulations requiring user facility 
and distributor adverse event reporting (hereinafter referred to as the 
November 1991 tentative final rule). In this November 1991 tentative 
final rule, FDA also proposed to amend the existing manufacturer 
reporting regulations to conform to the proposed user facility and 
distributor reporting requirements.
    After FDA's issuance of the November 1991 tentative final rule, the 
Medical Device Amendments of 1992 (Pub. L. 102-300) (the 1992 
amendments) were enacted on June 16, 1992, and amended certain 
provisions of section 519 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360i) relating to reporting of adverse device events.
    On December 11, 1995 (60 FR 63578), FDA published the MDR 
regulation for user facilities and manufacturers, based on comments to 
the November 1991 tentative final rule. In the Federal Register of 
April 11, 1996 (61 FR 16043), the effective date of this final rule was 
extended to July 31, 1996, in order to provide additional time for 
compliance. The requirements for manufacturer and user facility 
reporting are found at 21 CFR part 803.

II. Draft Guidance for Manufacturers

    Due to the diversity and complexity of medical device products, no 
regulation could address each possible reporting scenario. Therefore, 
the agency is providing additional guidance to the industry. The agency 
has developed a draft guidance document entitled ``Medical Device 
Reporting for Manufacturers.'' This draft guidance contains information 
describing: Who is covered by the MDR rule, who is responsible for 
reporting, how to report, and when to report. The draft guidance also 
contains statements of FDA policy, interpretations of the regulation, 
and answers to frequently asked questions. The agency also addresses in 
this guidance, many questions which have been raised after to the 
publication of the November 1991 tentative final rule. However, because 
the agency anticipates that additional new questions and issues may be 
raised as the effective date of the MDR regulation approaches, the 
agency is issuing the manufacturer guidance as a draft document and 
specifically invites questions and comments on matters not already 
addressed in the draft guidance. The agency will consider all submitted 
comments when revising the draft guidance. The agency anticipates that 
a revised guidance document for manufacturers will be available by 
November 27, 1996. In the interim, FDA believes the information 
contained in the draft guidance will be useful to medical device 
manufacturers as they seek to implement the requirements of the new MDR 
final rule.

III. Significance of a Guidance

    A guidance document does not bind FDA or the public, and does not 
create or confer any rights, privileges, or benefits for or on any 
person; however, it does represent the agency's current thinking on the 
subjects discussed therein. The draft guidance document announced in 
this notice represents the agency's tentative thinking on issues 
related to manufacturer reporting.

IV. Request for Comments

    Interested persons may, on or before August 29, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
the draft guidance entitled ``Medical Device Reporting for 
Manufacturers.'' Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified by 
the title of the guidance and the docket number found in brackets in 
the heading of this document. Copies of the guidance documents and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.
    Received comments will be considered in revising the draft guidance 
document.

    Dated: May 21, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-13665 Filed 5-30-96; 8:45 am]
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