[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Notices]
[Pages 49782-49783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19939]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Evaluation of Sex-Specific Data in Medical Device Clinical 
Studies; Guidance for Industry and Food and Drug Administration Staff; 
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 entitled ``Evaluation of Sex-Specific Data 
in Medical Device Clinical Studies.'' This document provides guidance 
on the study and evaluation of sex-specific data in medical device 
clinical studies, and it outlines the Center for Devices and 
Radiological Health's (CDRH's) and Center for Biologics Evaluation and 
Research's (CBER's) expectations regarding sex-specific patient 
enrollment, data analysis, and reporting of device study information. 
The guidance is intended to improve the quality and consistency of 
available data regarding the performance of medical devices in both 
sexes by encouraging appropriate enrollment by sex in clinical studies 
of devices, and appropriate interpretation and assessment if data from 
such studies are analyzed by sex. Evaluation of sex-specific data in 
medical device clinical studies can benefit patients, their medical 
providers, clinical researchers, and others.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Evaluation of Sex-Specific Data in Medical Device Clinical Studies'' 
to the Office of the Center Director, Guidance and Policy Development, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5431, Silver 
Spring, MD 20993-0002; or the Office of Communication, Outreach and 
Development, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 3128, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.
    Submit electronic comments on the 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: Jismi Johnson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424; 
or Kathryn O'Callaghan, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 
3614, Silver Spring, MD 20993-0002, 301-796-6349; or Stephen Ripley, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 7301, Silver 
Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of this guidance is to outline CDRH's and CBER's 
expectations regarding sex-specific patient enrollment, data analysis, 
and reporting of medical device study information. The intent is to 
improve the quality and consistency of available data regarding the 
performance of medical devices in both sexes by encouraging appropriate 
enrollment by sex in clinical studies of devices, and appropriate 
interpretation and assessment when data from such studies are analyzed 
by sex. This information can benefit patients, their medical providers, 
clinical researchers, and others. The specific objectives of this 
guidance are to: (1) Encourage the consideration of sex and associated 
covariates (e.g., body size, plaque morphology, etc.) during the study 
design stage; (2) provide recommendations for study design and conduct 
to encourage appropriate enrollment of each sex (e.g., in proportions 
generally representative of the demographics of disease distribution, 
if appropriate); (3) outline recommended sex-specific statistical 
analyses of study data with a framework for considering sex-specific 
data when interpreting overall study outcomes; and (4) specify FDA's 
expectations for reporting sex-specific information in summaries and 
labeling for approved or cleared medical devices.
    In the Federal Register of December 19, 2011 (76 FR 78670), FDA 
announced the availability of the draft guidance document. Interested 
persons were invited to comment by March 19, 2012. Multiple comments 
were received with recommendations pertaining to the evaluation of sex-
specific data in clinical studies. In response to these comments, FDA 
revised the guidance document to clarify the processes of sex-specific 
data evaluation in clinical studies and policies as appropriate. For 
more clarity, a decision framework for different clinical study designs 
was added to the guidance in response to comments received requesting 
additional information on when various sex-specific statistical 
recommendations would apply. Additionally, several comments requested 
that the recommendations in the guidance apply

[[Page 49783]]

to the demographic subgroups of age, race, and ethnicity. However, this 
is outside of the scope of the revised guidance but, where applicable, 
the guidance was updated with links to other guidances and information 
related to these other demographic subgroups.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on evaluation of sex-specific data 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 guidance may do so by 
downloading an electronic copy from 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 or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Persons 
unable to download an electronic copy of ``Evaluation of Sex-Specific 
Data in Medical Device Clinical Studies,'' may send an email request to 
[email protected] to receive an electronic copy of the 
document. Please use the document number 1727 to identify the guidance 
you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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; and the collections of 
information in 21 CFR part 822 have been approved under OMB control 
number 0910-0449.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-19939 Filed 8-21-14; 8:45 am]
BILLING CODE 4164-01-P