[Federal Register Volume 66, Number 76 (Thursday, April 19, 2001)]
[Notices]
[Pages 20149-20150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9652]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0785]


Guidance on Medical Device Patient Labeling; 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 the guidance document entitled ``Guidance on Medical 
Device Patient Labeling.'' This 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 
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 at any time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Guidance on Medical Device 
Patient Labeling'' to the Division of Small Manufacturers Assistance 
(HFZ-220), Center for Devices and Radiological Health, 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 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 
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 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 to help 
assure the safe and effective use of devices. This guidance document 
was published for public comment on March 3, 2000, as a draft proposal 
entitled ``Guidance on Medical Device Patient Labeling.''
    Both the draft guidance document and the March 2000 notice provided 
an opportunity for public comment, which closed June 2, 2000. Based on 
the comments received, the following substantive changes have been 
incorporated into the final version of the guidance.
    1. FDA inserted a paragraph in ``What is the purpose of this 
guidance?'' explaining that when translating the professional label 
into lay language, care should be taken to ensure that the lay language 
does not alter the intent of the indications, contraindications, 
warnings and precautions, or other parts of the labeling.
    2. The sections ``When should you use medical device patient 
labeling?'' and ``Determining Sequence and Content'' were restructured 
and revised for clarity. Both sections were clarified to focus on the 
needs of the specific target population for the device rather than an 
inflexible formula.
    3. The section entitled ``Alternatives to the device and 
treatment'' was deleted.
    4. Changes were made to address the safe and proper methods of 
disposing of medical devices.
    5. FDA has clarified that clinical studies information can be 
provided either as part of the patient labeling, or upon request.

II. Significance of Guidance

    This 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 statutes and regulations.
    The agency has adopted the good guidance practices (GGP's) 
regulation, which sets forth the agency's policies and procedures for 
the development, issuance, and use of guidance documents (21 CFR 
10.115; 65 FR 56468, September 19, 2000). This 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 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 the 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 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 Internet. Updated 
on a regular basis, the CDRH home page includes ``Guidance on 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.

[[Page 20150]]

 The CDRH home page may be accessed at http://www.fda.gov/cdrh. 
``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 the guidance at any time. 
Such comments will be considered when determining whether to amend the 
current guidance. Two copies of any comments are to be submitted, 
except that individual may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The guidance document is available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: April 2, 2001.
Linda S. Kahan,
Deputy Director for Regulations and Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-9652 Filed 4-18-01; 8:45 am]
BILLING CODE 4160-01-S