[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notice of availability of, and requesting comments on, a draft guidance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]
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