Evaluation of Sex-Specific Data in Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability, 49782-49783 [2014-19939]

Download as PDF 49782 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Notices ‘‘FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data’’ is being issued with this notice and is available at http://www.fda.gov/ RegulatoryInformation/;Legislation/ FederalFoodDrugand CosmeticActFDCAct/ SignificantAmendmentstotheFDCAct/ FDASIA/ucm356316.htm. FDA is reopening the docket for 60 days to provide an opportunity for interested individuals to submit comments on the action plan. When submitting comments please reference the section of the action plan to which your comments pertain. This docket is intended to ensure that stakeholders have an opportunity to provide comments and that such information submitted to FDA is available to all interested persons in a timely fashion. II. How to Submit 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 15, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–19881 Filed 8–21–14; 8:45 am] BILLING CODE 4164–01–P 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. 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 tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:23 Aug 21, 2014 Jkt 232001 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 sexspecific 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 SexSpecific 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, PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 sexspecific 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 E:\FR\FM\22AUN1.SGM 22AUN1 Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Notices 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 sexspecific 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. tkelley on DSK3SPTVN1PROD with NOTICES 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/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Persons unable to download an electronic copy of ‘‘Evaluation of SexSpecific 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 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 VerDate Mar<15>2010 16:23 Aug 21, 2014 Jkt 232001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Revamping Microbiological Test Methods for Contact Lenses Products; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA), the American Academy of Ophthalmology (AAO), the American Academy of Optometry (AAOpt), the American Optometric Association (AOA), and the Contact Lens Association of Ophthalmologists, Inc. (CLAO), are cosponsoring a public workshop entitled ‘‘Revamping Microbiological Test Methods for Contact Lenses, Products, and Accessories.’’ The purpose of this workshop is to discuss adequate testing of contact lens care products for disinfection efficacy against emerging pathogens as well as common infectious etiologies. Participants will explore the pros and cons of the various proposals for disinfection efficacy testing and aid in developing general recommendations. The workshop will assist in informing the regulatory science for evaluating contact lenses and disinfection efficacy of associated care products as well as improving test methods to mitigate potential infections. DATES: Date and Time: The public workshop will be held on September 12, SUMMARY: PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 49783 2014, from 8 a.m. to 5 p.m. Sign-in will open at 7:30 a.m. ADDRESSES: Location: The public workshop will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503A), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Contact Person: Jeffrey Brocious, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2252, Silver Spring, MD 20993, 240– 402–3797, email: Jeffrey.Brocious@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Registration: Registration is $250 for members of the AAO, AAOpt, AOA, or CLAO; or $400 for non-members and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by September 5, 2014, at 4 p.m. EDT. There will be no onsite registration on the day of the public workshop. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If you need special accommodations due to a disability, please contact Ms. Susan Monahan at susan.monahan@fda.hhs.gov or 301– 796–5661 no later than August 28, 2014. To register for the public workshop, please visit http://www.clwkshop.org/. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. If there are any questions with registration, please contact Ms. Cindy Groff at cgroff@convergence-us.com. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Food and beverages will be available for purchase by participants during the workshop breaks. For more information on the workshop, please see the FDA’s Medical Devices News & Events— Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. (Select this public workshop from the posted events list.) Streaming Webcast of the Public Workshop: The public workshop will E:\FR\FM\22AUN1.SGM 22AUN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
CDRH-Guidance@fda.hhs.gov 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