[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67463-67465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28244]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0754]
Pediatric Medical Devices; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Using Scientific Research Data to Support Pediatric
Medical Device Claims: A Public Dialogue.'' The purpose of the public
workshop is to receive public comment on the use of scientific research
data, including published scientific literature, to support and
establish pediatric indications for medical devices.
The topics to be discussed are: The ways scientific research data
can be used to support pediatric effectiveness claims for medical
devices and pediatric device approvals or clearance; the scientific and
regulatory limitations and issues of using existing scientific research
data to support pediatric effectiveness claims and pediatric indication
approvals for medical devices; and methods to overcome the pitfalls and
data gaps, including statistical approaches and modeling.
Date and Time: The public workshop will be held on December 5,
2011, from 8:30 a.m. to 5 p.m. EST.
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Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (rm. 1503), Silver Spring, MD 20993-0002.
Contact Person: Carol Krueger, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 5437, Silver Spring, MD 20993-0002, (301) 796-3241,
Carol.Krueger@fda.hhs.gov.
Registration: Registration is free and on a first-come, first-
served basis. Persons interested in attending this workshop must
register online by 5 p.m. on November 28, 2011. 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 on the day of the public workshop
will be provided beginning at 7:30 a.m. If you need special
accommodations due to a disability, please contact Cynthia Garris
(email: Cynthia.Garris@fda.hhs.gov or (301) 796-5861) no later than
November 28, 2011.
To register for the public workshop, please visit the following Web
site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go the FDA Medical Devices News &
Events--Workshops & Conferences calendar and select this public
workshop from the posted events list). Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone number. Those without Internet access
should contact Carol Krueger to register (see Contact Person).
Registrants will receive confirmation after they have been accepted.
You will be notified if you are on a waiting list.
Streaming Web Cast of the Public Workshop: This workshop will also
be Web cast. Persons interested in viewing the Web cast must register
online by 5 p.m. on November 28, 2011. Early registration is
recommended because Web cast connections are limited. Organizations are
requested to register all participants but to view using one connection
per location. Web cast participants will be sent technical system
requirements after registration and will be sent connection access
information after November 28th. If you have never attended a Connect
Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
Workshop Format: This workshop is structured as topic-focused
breakout sessions, intended to foster constructive dialogue between
stakeholders with diverse perspectives. Moderators of each small group
will summarize the group discussion and present it to the participants.
Comments: FDA is holding this public workshop to obtain information
on a number of questions regarding factors affecting approval or
clearance of devices for use with a pediatric population. In order to
permit the widest possible opportunity to obtain public comment, FDA is
soliciting written or electronic comments on all aspects of the
workshop topics. The deadline for submitting comments related to this
public workshop is January 5, 2012.
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 necessary to
send only one set of comments. It is no longer necessary to send two
copies of mailed comments. Please identify written comments with the
docket number found in brackets in the heading of this document. In
addition, when responding to specific questions as outlined in section
II of this document, please identify the question 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.
SUPPLEMENTARY INFORMATION:
I. Background
In 2007, Congress passed the Pediatric Medical Device Safety and
Improvement Act (the Act). The Act addresses pediatric device needs by
providing financial incentives for development, production, approval
and distribution of new devices for rare and unmet pediatric needs;
allowing for a pediatric device approval pathway that permits
extrapolation of adult effectiveness data to support a pediatric
indication based on similar course of the disease or condition or a
similar effect of the device; and providing grants to pediatric device
consortia that provide technical support and assistance to pediatric
device innovators.
This workshop will support FDA's efforts to define pathways for
approving pediatric device indications by leveraging available
scientific research data. An important, but not the only, focus will be
a discussion of how to determine when it is appropriate to use, and how
to use, existing scientific research data to determine pediatric
effectiveness based on a similar course of a disease or condition or a
similar effect of a device on adults and similar extrapolation between
pediatric subpopulations.
The demand by health care professionals and consumers for safe and
effective pediatric medical devices continues to steadily increase.
Pediatric medical devices treat or diagnose diseases and conditions
occurring from birth through the 21st year of life. Some devices are
designed specifically for pediatric use, while others are adopted from
specific adult device applications or produced for more general use.
Designing pediatric medical devices can be challenging; children
are often smaller and more active than adults, body structures and
functions change throughout childhood, and children may be long-term
device users--bringing new concerns about device longevity and long-
term exposure to implanted materials. The current medical device market
for children has a higher demand than supply. FDA is committed to
supporting the development and availability of safe and effective
pediatric medical devices.
Through this effort, FDA and stakeholders will take steps to
increase awareness of a path for approval of pediatric devices that
uses certain literature. FDA can advance this goal by collaborating
with stakeholders, including medical device and health care industries,
and the health care provider and consumer communities.
II. Topics for Discussion at the Public Workshop
The public workshop will be organized to discuss the following
topic areas:
A. The use of existing scientific research data to support
pediatric effectiveness claims for medical devices and pediatric device
approvals or clearance,
B. The scientific and regulatory limitations and issues with the
use of existing scientific research data, and
C. The methods to overcome the pitfalls and data gaps, including
statistical approaches and modeling.
III. Transcripts
Please be advised that as soon as a transcript is available, it
will be
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accessible at http://www.regulations.gov. It may be viewed at the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
A link to the transcripts will also be available on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select this public workshop from the posted events list),
approximately 45 days after the public workshop.
Dated: October 26, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-28244 Filed 10-31-11; 8:45 am]
BILLING CODE 4160-01-P