
[Federal Register Volume 76, Number 243 (Monday, December 19, 2011)]
[Notices]
[Pages 78670-78671]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32368]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0817]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Evaluation of Sex Differences in Medical Device Clinical 
Studies; 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availability of the draft guidance entitled ``Evaluation of Sex 
Differences in Medical Device Clinical Studies.'' This document 
provides guidance on the study and evaluation of sex differences in 
medical device clinical trials, with a specific focus on addressing 
potential differences in study design, conduct, outcomes, and 
interpretation that should be considered to ensure sex-specific issues 
are adequately addressed in clinical trials. This draft guidance is not 
final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 19, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Evaluation of Sex Differences in Medical 
Device Clinical Studies'' to the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to (301) 847-8149. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 1546, Silver Spring, MD 20993-0002, 
(301) 796-6349.

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of this guidance is to outline the Center for Devices 
and Radiological Health's (CDRH's) expectations regarding sex-specific 
patient enrollment, data analysis, and reporting of study information. 
The intent is to improve the quality and consistency of available data 
regarding the performance of medical devices in women. This information 
can be of benefit to patients and their medical providers, as well as 
clinical researchers and others. The specific objectives of this 
guidance are to: (1) Better communicate the balance of risks and 
benefits of FDA-approved or cleared medical devices; (2) identify sex-
specific questions for further study; and (3) encourage the 
consideration of sex and associated covariates (e.g., body size, plaque 
morphology, etc.) during the trial design stage.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on ``Evaluation 
of Sex Differences in Medical Device Clinical Studies.'' 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 requirements of the applicable statute and 
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Evaluation of Sex Differences in Medical Device Clinical Studies,'' 
you may either send an email request to dsmica@fda.hhs.gov to receive 
an electronic copy of the document or send a fax request to (301) 847-
8149 to receive a hard copy. Please use the document number 1727 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 812.25(c) have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
part 807 Subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814 Subparts B and 
E have been approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 814 Subpart H have been 
approved under OMB control number 0910-0332; the collections of 
information in 21 CFR part 822 have been approved under OMB control 
number 0910-0449.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments.

[[Page 78671]]

Identify comments with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32368 Filed 12-16-11; 8:45 am]
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