[Federal Register Volume 65, Number 43 (Friday, March 3, 2000)]
[Notices]
[Pages 11586-11587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5086]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0785]


Draft Guidance for Industry; Guidance on Medical Device Patient 
Labeling;   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availability of a draft guidance entitled

[[Page 11587]]

``Guidance on Medical Device Patient Labeling.'' This draft guidance is 
not final nor is it in effect at this time. This draft guidance 
describes how to make medical device patient labeling understandable to 
and usable by patients (or family members or other lay persons caring 
for patients). It is intended to assist manufacturers in their 
development and reviewers in their review and evaluation of medical 
device patient labeling. This draft guidance is designed to help assure 
safe and effective use of medical devices through medical device 
patient labeling that informs patients or their lay caregivers about 
proper use, risks, and benefits of the device in language they can 
understand.

DATES: Submit written comments on this draft guidance by June 2, 2000.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Guidance on Medical Device Patient 
Labeling'' to the Division of Small Manufacturers Assistance (DSMA) 
(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. Submit written comments 
concerning this draft guidance to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Comments should be identified with the docket 
number found in brackets in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Paula G. Silberberg, Center for 
Devices and Radiological Health (HFZ-230), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-1217.

SUPPLEMENTARY INFORMATION:

I. Background

    The draft guidance provides information on the content, format, and 
organization of information that patients need to use medical devices 
safely and effectively. It also gives principles for writing and 
presenting patient information in a manner most understandable and 
usable to patients and their lay caregivers. With an increase in 
patient use of complex medical devices previously used primarily by 
skilled and knowledgeable health-care professionals, effective medical 
device patient labeling has become increasingly important in helping to 
assure the safe and effective use of devices.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on medical device patient 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 such approach 
satisfies the applicable statute, regulations, or both.
    The agency has adopted Good Guidance Practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This draft guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive ``Guidance on Medical Device Patient Labeling'' 
via your fax machine, call the CDRH Facts-On-Demand (FOD) 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 (1128) 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 Internet. CDRH maintains an entry on the Internet 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with access to the Intenet. 
Updated on a regular basis, the CDRH home page includes the Medical 
Device Patient Labeling, 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 home page may be accessed at http://www.fda.gov/cdrh. The document entitled ``Guidance on Medical Device Patient 
Labeling'' will be available at http://www.fda.gov/cdrh/HumanFactors.html.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance by June 
2, 2000. 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 document and received comments may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: February 28, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-5086 Filed 2-28-00; 4:36 pm]
BILLING CODE 4160-01-F