[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Notices]
[Pages 42819-42821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19259]


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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; 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 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 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.

DATES: The announcement of the guidance is published in the Federal 
Register on September 12, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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

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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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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; Guidance for 
Industry and Food and Drug Administration Staff; Availability.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 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 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 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: Katheryn O'Callaghan, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5418, 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 to improve 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 to 
improve 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 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.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of June 20, 2016 (81 FR 39927). FDA 
revised the guidance as appropriate in response to the comments. 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).

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 
current thinking of FDA on ``Evaluation and Reporting of Age, Race, and 
Ethnicity data in Medical Device Clinical

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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. 
This guidance is not subject to Executive Order 12866.

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 Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://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 [email protected] to receive an electronic copy of 
the document. Please use the document number 1500626 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously 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. References

    The following references are on display in the Dockets Management 
Staff office (see ADDRESSES) and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at https://www.regulations.gov. 
FDA has verified the Web site addresses, 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/SignificantAmendmentstotheFDCAct/FDASIA/UCM365544.pdf.
2. FDA's Action Plan to Enhance the Collection and Availability of 
Demographic Subgroup Data (August, 2014), available at https://www.fda.gov/downloads/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/UCM410474.pdf.
3. FDA's guidance entitled ``Evaluation of Sex-Specific Data in 
Medical Device Clinical Studies'' (August 22, 2014), available at 
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM283707.pdf.

    Dated: September 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19259 Filed 9-11-17; 8:45 am]
 BILLING CODE 4164-01-P