[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Pages 20928-20929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08015]



Food and Drug Administration

[Docket No. FDA-2013-N-0329]

Center for Devices and Radiological Health: Health of Women 
Program; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop: ``The Center for Devices and Radiological 
Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist 
and Explore--HoW to Improve the Health of Women.'' CDRH is developing 
the HoW Program to explore unique issues in the regulation of medical 
devices related to the health of women and seeks public input on the 
priority activities. The CDRH HoW program seeks to bring together 
industry, clinicians, researchers, academia, government agencies, and 
patient/advocacy groups in an effort to: (1) Highlight device-specific 
clinical Study recruitment and retention strategies; (2) improve 
analysis and communication of sex-specific findings to providers and 
patients; (3) develop a priority research road map for the HoW device 
ecosystem. The workshop focus will be device- and disease-specific, 
patient centered, and action oriented.
    Dates and Times: The public workshop will be held on June 24, 2013, 
from 8 a.m. to 5 p.m. and June 25, 2013, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held on FDA's White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993.
    Contact: Nada Hanafi, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5422, Silver Spring, MD 20993-0002, 301-796-5427, 
[email protected]; or Kathryn O'Callaghan, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5568, Silver Spring, MD 20993-0002, 301-796-6349, 
[email protected].
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by 5 p.m. on June 14, 2013. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permits, onsite registration will be 
provided beginning at 7:30 a.m. on the day of the public workshop.
    If you need special accommodations due to a disability, please 
contact Joyce Raines ([email protected] or 301-796-5709) by 5 
p.m. on June 14, 2013.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm 
and select this public workshop from the posted events list. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, telephone number and primary HoW 
Program area of expertise or interest. Registrants will receive 
confirmation after they have been accepted. You will be notified if you 
are on a waiting list.
    Streaming Webcast of the public workshop: The plenary portions of 

[[Page 20929]]

workshop will be Webcast. Persons interested in viewing the Webcast 
must register online by 5 p.m. on June 14, 2013. Early registration is 
recommended because Webcast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Webcast participants will be sent technical 
system requirements after registration and connection access 
information after June 19, 2013. An archived file of the Webcast will 
be available approximately 45 days after the public workshop on the 
Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the 
posted events list).
    Workshop format: This workshop will begin with plenary sessions to 
outline the three primary areas of focus for the CDRH HoW Program. In 
each area, panels will examine major themes using data-driven case 
studies with a focus on practical strategies relevant to particular 
challenges in the medical device arena. Participants will then rotate 
through breakout sessions, collectively building an action plan for 
each activity area. The meeting will conclude with specific commitments 
by stakeholder groups to partner with CDRH and each other in a 
collaborative effort to educate, enable, enlist and explore, with a 
common goal of improving the health of women.
    Comments: In order to permit the widest possible opportunity to 
obtain public information from interested persons on the workshop 
topics, FDA is opening the docket to gather electronic or written 
comments on the three areas of focus for the HoW workshop identified in 
section II. Comments received will be reviewed by FDA as part of this 
effort. The deadline for submitting comments related to this public 
workshop topic is July 31, 2013.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic or written comments. Submit electronic 
comments 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. It is only necessary 
to send one set of comments. Please identify comments with the docket 
number found in brackets in the heading of this document. In addition, 
when responding to specific topics as outlined in section II, please 
identify the topic you are addressing. 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.


I. Background

    The mission of the CDRH Health of Women (HoW) Program:
    To improve the health of women by:
     Improving the availability, consistency, and communication 
of sex-specific information for the safe and effective use of medical 
devices in women;
     addressing identified gaps and unmet needs through 
targeted resources; and
     fostering the development of innovative strategies, 
technology, and clinical study paradigms.
    A key priority in regulatory science for CDRH is improving the 
health of special populations and addressing their unique health-
related issues.\1\ CDRH recognizes women as a special population, and 
seeks to identify and address differences in the safety, effectiveness, 
and utilization of medical devices for women. There are unique issues 
in the regulation of medical devices for use by women, which include:

    \1\ Food and Drug Administration, ``Regulatory Science in FDA's 
Center for Devices and Radiological Health: A Vital Framework for 
Protecting and Promoting Public Health,'' http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm274162.pdf.

     Uncertainty about medical device performance in women due 
to inconsistent data analysis and under-representation of women in 
clinical trials
     Baseline differences in anatomy, physiology, risk factors, 
disease signs/symptoms, and comorbidities that may be associated with 
different outcomes of device use
     Potential differences in health communication/health 
seeking behavior that may impact FDA communication of medical device 
benefit-risk information to this population
     Different considerations regarding effects of hormones 
through life stages (first menstrual period (menarche) to menopause; 
hormone replacement therapy)
     Unique risks and needs related to medical device research 
involving women of childbearing potential
     Unique risks and needs for pregnant females associated 
with the use of medical devices, including risk of birth defects 
(teratogenicity) or complications of pregnancy arising from medical 
device components such as drugs, chemicals, and certain biomaterials

II. Topics for Discussion in the Docket and at the Public Workshop

    Topics for discussion include:
    1. Device-specific clinical study recruitment and retention 
    2. Analysis and communication of sex-specific findings to providers 
and patients; and
    3. Priority research road map for the HoW device ecosystem.

    Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08015 Filed 4-5-13; 8:45 am]