[Federal Register: April 19, 2001 (Volume 66, Number 76)]
[Notices]
[Page 20149-20150]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap01-44]
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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