
[Federal Register Volume 81, Number 118 (Monday, June 20, 2016)]
[Notices]
[Pages 39927-39929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14461]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0734]


Evaluation and Reporting of Age, Race, and Ethnicity Data in 
Medical Device Clinical Studies; Draft Guidance for Industry and Food 
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Evaluation and 
Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical 
Studies.'' The purpose of this document is to outline FDA's proposed 
recommendations and expectations for the evaluation and reporting of 
age, race, and ethnicity data in medical device clinical studies. The 
primary intent of these recommendations is to improve the quality, 
consistency, and transparency of data regarding the performance of 
medical devices within specific age, race, and ethnic groups. 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draft guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 19, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-0734 for ``Evaluation and Reporting of Age, Race, and 
Ethnicity Data in Medical Device Clinical Studies.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 draft guidance document entitled 
``Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical 
Device Clinical Studies'' to the Office of the Center Director, 
Guidance and Policy Development, Center for Devices and

[[Page 39928]]

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.

FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5428, 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 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 907 of the Food and Drug Administration Safety and 
Innovation Act (Pub. L 112-144) (FDASIA) directed the Agency to publish 
and provide to Congress a report describing the extent to which 
clinical trial participation and safety and effectiveness data by 
demographic subgroups, including sex, age, race, and ethnicity, is 
included in applications submitted to FDA (Ref 1). Section 907 also 
directed FDA to publish and provide to Congress an action plan 
outlining recommendations for improving the completeness and quality of 
analyses of data on demographic subgroups in summaries of product 
safety and effectiveness data and in labeling; on the inclusion of such 
data, or the lack of availability of such data, in labeling; and on 
improving the public availability of such data to patients health care 
providers and researchers, and to indicate the applicability of these 
recommendations to the types of medical products addressed in section 
907. In the Action Plan, FDA committed to developing this draft 
guidance as part of the strategy to fulfill FDASIA requirements (Ref. 
2).
    This guidance outlines FDA's recommendations and expectations for 
patient enrollment, data analysis, and reporting of age, race, and 
ethnicity data in medical device clinical studies. Specific objectives 
of this guidance are to (1) encourage the collection and consideration 
of age, race, ethnicity, and associated covariates (e.g., body size, 
biomarkers, bone density) during the study design stage; (2) outline 
recommended analyses of study subgroup data with a framework for 
considering demographic data when interpreting overall study outcomes; 
and (3) specify FDA's recommendations for reporting age, race, and 
ethnicity-specific information in summaries and labeling for approved 
or cleared medical devices. FDA believes these recommendations will 
help improve the quality, consistency, and transparency of data 
regarding the performance of medical devices within specific age, race, 
and ethnic groups as well as encourage appropriate enrollment of 
diverse populations including relevant age, race, and ethnic groups. 
Proper evaluation and reporting of these data can benefit patients, 
clinicians, researchers, regulators, and other stakeholders.
    This document extends the policy established in FDA's guidance 
entitled ``Evaluation of Sex-Specific Data in Medical Device Clinical 
Studies'' to additional demographic subgroups of age, race, and 
ethnicity (Ref. 3). Upon finalization of this draft guidance, FDA 
intends to integrate the content of both guidances into one document.

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 current thinking of FDA on the evaluation 
and reporting of age, race, and ethnicity data in medical device 
clinical studies. It does not establish any rights for any person and 
is not binding on FDA or the public. You can use an alternative 
approach if it satisfies the requirements of the applicable statutes 
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to 
download an electronic copy of ``Evaluation and Reporting of Age, Race, 
and Ethnicity Data in Medical Device Clinical Studies'' may send an 
email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number 1500026 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). These 
collections of information in 21 CFR part 812 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 A 
through 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; and the collections of information in 21 CFR part 801 
have been approved under OMB control number 0910-0485.

V. Reference

    The following reference is on display in the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA Report: Collection, Analysis, and Availability of Demographic 
Subgroup Data for FDA-Approved Medical Products, issued August 2013, 
required under FDASIA section 907, available at http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM365544.pdf.
2. FDA's Action Plan to Enhance the Collection and Availability of 
Demographic Subgroup Data (August, 2014), available at http://www.fda.gov/downloads/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/UCM410474.pdf.
3. FDA's guidance entitled ``Evaluation of Sex-Specific Data in 
Medical Device Clinical Studies'' (August 22, 2014), available at 
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm283707.pdf.


[[Page 39929]]


    Dated: June 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14461 Filed 6-17-16; 8:45 am]
 BILLING CODE 4164-01-P


