[Federal Register Volume 62, Number 148 (Friday, August 1, 1997)]
[Notices]
[Pages 41397-41398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0304]


Draft Guidance on Medical Device Labeling--Suggested Form and 
Content; 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availability of a draft guidance for medical devices entitled ``Medical 
Device Labeling--Suggested Form and Content.'' The draft guidance is 
intended to assist the device manufacturers in designing labeling and 
FDA in evaluating labeling and to promote clarity and uniformity in 
medical device labeling. The draft guidance identifies a suggested 
content for device labeling and each element of the suggested labeling 
is discussed.
DATES: Written comments concerning this draft guidance must be received 
by October 30, 1997.
ADDRESSES: Written comments concerning this draft guidance must be 
submitted to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 
Comments should be identified with the docket number found in brackets 
in the heading of this document. Submit written requests for single 
copies of ``Medical Device Labeling--Suggested Form and Content'' to 
the Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health (CDRH), Food and Drug Administration, 
1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Dan A. Spyker, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8320, or e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION:

I. Background

    There are labeling requirements for medical devices in the Federal 
Food, Drug, and Cosmetic Act (the act) and in the regulations issued 
under the act in Title 21 of the Code of Federal Regulations (CFR). 
General labeling requirements can be found in 21 CFR part 801, while 
detailed and specific labeling requirements for in vitro diagnostic 
products appear in 21 CFR 809.10. In 1991 FDA issued a Blue Book 
Memorandum #G91-1, entitled ``Device Labeling Guidance.'' The ``Device 
Labeling Guidance'' has been in use since it was issued, but CDRH 
studies and experience have demonstrated a need for greater direction 
in the format and content of device labeling. Therefore, this updated 
and expanded guidance has been drafted. Neither the act nor the 
regulations provide specific definitions or explanations of some 
significant labeling terms such as warnings, precautions, 
contraindications and adverse events. Because labeling is a key factor 
in the FDA clearance of premarket notifications (510(k)'s) and approval 
of premarket approval applications (PMA's), it is important that 
manufacturers and FDA personnel have a common understanding of how 
these terms and other elements of labeling are defined. An alternative 
approach may be used if such approach satisfies the applicable statute 
and regulations. Furthermore, this draft guidance will not be 
retrospective; it is intended for use in the preparation and review of 
labeling prior to the issuance of a final FDA decision.
    This draft guidance represents the agency's current thinking on 
device labeling. 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

[[Page 41398]]

such approach satisfies the applicable statute, regulations, or both.

II. Comments

    Interested persons may, on or before October 30, 1997, submit to 
the Dockets Management Branch (address above) written comments 
regarding this draft guidance. 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 draft guidance and received comments may be seen 
in the office above between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    In order to receive the ``Medical Device Labeling--Suggested Form 
and Content'' draft guidance via your fax machine, call the CDRH Facts-
On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. At the first voice prompt press 1 to access DSMA Facts, at 
second voice prompt press 2, and then enter the document number 119 
followed by the pound sign (#). Then follow the remaining voice prompts 
to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the World Wide Web (www). CDRH maintains an entry on 
the World Wide Web for easy access to information including text, 
graphics, and files that may be downloaded to a PC with access to the 
Web. Updated on a regular basis, the CDRH homepage includes the 
``Medical Device Labeling--Suggested Form and Content'' draft guidance, 
device safety alerts, Federal Register reprints, information on 
premarket submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturers' assistance, information 
on video conferencing and electronic submissions, mammography matters, 
and other device-oriented information. The CDRH homepage may be 
accessed at ``http://www.fda.gov/cdrh''. The ``Medical Device 
Labeling--Suggested Form and Content'' draft guidance is available at 
``http://www.fda.gov/cdrh/draftgui.html''.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 compatible terminal by dialing 800-222-0185 
(terminal settings are 8/1/N). Once the modem answers, press Enter 
several times and then select menu choice 1: FDA BULLETIN BOARD 
SERVICE. Select menu choice 1-FDA Bulletin Board Service. At login 
prompt type ``bbs'' and hit Enter, at password prompt type ``bbs'' and 
hit Enter, at this screen, hit Enter (brings you to FDA Home Page), 
using tab key, select Medical Devices/Radiological Health--hit Enter, 
using
tab key, select Topic Index--hit Enter, using tab key, select ``L''--
hit Enter, under ``Labeling'' is the title of the draft guidance 
``Medical Device Labeling-Suggested Form and Content''--select text 
file--hit Enter, use space bar to move page to page, in order to view 
the whole document.

    Dated: July 2, 1997.
Joseph A. Levitt.
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-20313 Filed 07-31-97; 8:45 am]
BILLING CODE 4160-01-F