[Federal Register Volume 61, Number 106 (Friday, May 31, 1996)]
[Notices]
[Pages 27360-27361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13666]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96D-0148]


Medical Devices; Medical Device User Facility and Distributor 
Reporting; Guidance Documents; 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 three guidance documents entitled ``Medical Device 
Reporting: An Overview,'' ``Medical Device Reporting for User 
Facilities,'' and ``Medical Device Reporting for Distributors.'' These 
guidance documents provide information to help facilitate compliance 
with the agency's Medical Device Reporting (MDR) requirements. The 
agency is also announcing the availability of the following final MDR 
reporting forms: FDA Form 3419, Semiannual User Facility Report; FDA 
Form 3417, Baseline Report; and FDA Form 3381, Annual Certification. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
notice of availability of, and requesting comments on, a draft guidance 
document focusing on reporting by manufacturers.

DATES: Written comments on the guidance documents may be submitted at 
any time.

ADDRESSES: Submit written comments on the three guidance documents to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments on the 
three guidance documents should be kept separate and identified by 
their respective titles. Requests and comments should be identified 
with the docket number found in brackets in the heading of this 
document. A copy of the guidance documents and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Persons interested in obtaining copies of the guidance documents 
and reporting forms may use 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 scroll down to Medical Device Reporting. The documents will 
be listed and available for downloading.
    Anyone with a video terminal or personal computer with a modem can 
obtain these documents from the electronic docket administered by DSMA 
(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 about obtaining paper copies of these documents through the 
CDRH Facts-on-Demand system by dialing 1-800-899-

[[Page 27361]]

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 these 
documents 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

    On November 26, 1991 (56 FR 60024), under the Safe Medical Devices 
Act of 1990 (Pub. L. 101-629), 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 the 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.
    Subsequent to FDA's issuance of the November 1991 tentative final 
rule, the Medical Device Amendments of 1992 (Pub. L. 102-300) 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), the agency published the MDR 
regulation for user facilities and manufacturers, based on comments to 
the November 1991 tentative final rule. The requirements for 
manufacturer and user facility reporting are found in part 803 (21 CFR 
part 803). The reporting requirements for distributors fell under a 
different implementation timetable. On May 28, 1992, the provisions of 
the November 1991 tentative final rule pertaining to distributor 
reporting became final by operation of law. Accordingly, medical device 
distributors are currently subject to the reporting regulations 
contained in the November 1991 tentative final rule and codified in 
part 804 (21 CFR part 804). FDA intends to issue a proposed rule to 
make the distributor reporting requirements consistent with the 
manufacturer and user facility reporting requirements.

A. Guidance for User Facilities and Distributors

    Due to the diversity and complexity of medical device products, no 
regulation could address each possible reporting scenario. Therefore, 
the agency is providing three guidance documents entitled ``Medical 
Device Reporting: An Overview,'' ``Medical Device Reporting for User 
Facilities,'' and ``Medical Device Reporting for Distributors.'' These 
guidance documents contain information describing who is covered by the 
MDR rule, who is responsible for reporting, how to report, and when to 
report. The documents also contain statements of FDA's policy, 
interpretations of the regulation, and answers to frequently asked 
questions. Elsewhere in this issue of the Federal Register, FDA is 
publishing a notice of availability of, and requesting comments on, a 
draft guidance document focusing on reporting by manufacturers.

B. MDR Reporting Forms

    The MDR final rule requires that MDR reports be submitted using the 
appropriate form, or an approved electronic equivalent. The actual 
forms were made available for public comment, were approved by the 
Office of Management and Budget (OMB) through February 28, 1999, under 
OMB control number 0910-0059, and were announced as final in the 
Federal Register of April 11, 1996 (61 FR 16043). The April 11, 1996, 
final rule also extended the effective date of the MDR final rule for 
manufacturers and user facilities to July 31, 1996, in order to provide 
additional time for compliance. This notice announces the availability 
of the following MDR forms: FDA Form 3419, Semiannual User Facility 
Report; FDA Form 3417, Baseline Report; and FDA Form 3381, Annual 
Certification. FDA Form 3500A, the MEDWATCH Form, has been in use for 
several years and is available from the same sources listed above. This 
form, or an approved electronic equivalent, will continue to be used 
for reporting individual adverse events. Although manufacturers, 
distributors, and device user facilities may immediately begin using 
the forms announced in this notice to submit reports required under the 
MDR regulations, use of the forms will not be required until July 31, 
1996, the effective date of the MDR final rule.

II. 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.

III. Request for Comments

     All guidance documents developed by FDA are open to public 
comment. Therefore, interested persons may submit comments regarding 
the final guidance documents that are being announced in this notice. 
Interested persons may, at any time, submit to the Dockets Management 
Branch (address above) written comments regarding the three guidance 
documents. 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 respective guidance document and with the docket number 
found in brackets in the heading of this document. Copies of the three 
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 reviewing and revising the 
guidance documents.

    Dated: May 21, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-13666 Filed 5-30-96; 8:45 am]
BILLING CODE 4160-01-F