[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67463-67465]
From the Federal Register Online via the Government Publishing 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, 
[email protected].
    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: [email protected] 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