Federal Register / Vol. 61, No. 106 / Friday, May 31, 1996 / Notices 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

[Docket No. 96D–0137]

Medical Device Reporting, Draft

Guidance Document for

Manufacturers; Notice of Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

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
27362 Federal Register / Vol. 61, No. 106 / Friday, May 31, 1996 / Notices

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]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Mental Health;

Notice of Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings of the National Institute of

Mental Health Special Emphasis Panel:

Agenda/Purpose: To review and evaluate

grant applications.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: June 12, 1996.

Time: 6 p.m.

Place: Chevy Chase Holiday Inn, 5520

Wisconsin Avenue, Chevy Chase, MD 20815.

Contact Person: Michael D. Hirsch,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857.

Telephone: 301, 443–1000.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: June 14, 1996.

Time: 12 p.m.

Place: Chevy Chase Holiday Inn, 5520

Wisconsin Avenue, Chevy Chase, MD 20815.

Contact Person: Michael D. Hirsch,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857.

Telephone: 301, 443–1000.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: June 20, 1996.

Time: 8;30 a.m.

Place: The Latham Hotel Georgetown, 3000

M Street, NW., Washington, DC 2007.

Contact Person: Phyllis D. Artis, Parklawn

Building, Room 9C–26, 5600 Fishers Lane,