Pediatric Medical Devices; Public Workshop; Request for Comments, 67463-67465 [2011-28244]
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Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices
67463
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS—Continued
Date
Electronic address
Address
(non-electronic)
Other information
Make a request for oral
presentation.
Submit a request by
November 10, 2011.
https://www.fda.gov/Food/News
Events/WorkshopsMeetingsConferences/default.htm.
......................................
Provide a brief description of the oral presentation and any written material for the
presentation.
By November 21, 2011
https://www.fda.gov/Food/
NewsEvents/WorkshopsMeetings
Conferences/default.htm.
......................................
Submit electronic or
written comments.
Submit comments by
January 30, 2012.
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Fax: 301–827–6870,
Mail/Hand delivery/
Courier (for paper,
disk, or CD–ROM
submissions): Division of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm.
1061, Rockville, MD
20852.
Requests made on the day of the meeting to
make an oral presentation will be granted as
time permits. Information on requests to
make an oral presentation may be posted
without change to https://www.regulations.gov,
including any personal information provided.
Written material associated with an oral presentation should be submitted in Microsoft
PowerPoint, Microsoft Word, or Adobe Portable Document Format (PDF) and may be
posted
without
change
to
https://
www.regulations.gov, including any personal
information provided.
All comments must include the Agency name
and the docket number corresponding to the
Cosmetic Microbiological Safety Issues; Public Meeting. All received comments may be
posted
without
change
to
https://
www.regulations.gov, including any personal
information provided. FDA encourages the
submission of electronic comments by using
the Federal eRulemaking Portal. For additional information on submitting comments,
see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of
this document.
IV. Comments
Regardless of attendance at the public
meeting, interested persons may submit
to the Division of Dockets management
(see Table 1 of this document) either
electronic or written comments for
consideration at or after the meeting in
addition to, or in place of, a request for
an opportunity to make an oral
presentation. It is only necessary to send
one set of comments. It is no longer
necessary to send two copies of mailed
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be viewed in the
Division of Dockets Management at the
address provided in Table 1 of this
document between 9 a.m. and 4 p.m.,
Monday through Friday.
srobinson on DSK4SPTVN1PROD with NOTICES
V. References
We have placed hard copies of the
following references on display in the
Division of Dockets Management (see
ADDRESSES). You may view them
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses, but FDA is not
responsible for any subsequent changes
to Web sites after this document
publishes in the Federal Register.)
1. FDA, ‘‘Good Manufacturing
Practice (GMP) Guidelines/Inspection
Checklist,’’ available at https://
www.fda.gov/Cosmetics/Guidance
ComplianceRegulatoryInformation/
GoodManufacturingPracticeGMP
GuidelinesInspectionChecklist/
default.htm.
VerDate Mar<15>2010
17:04 Oct 31, 2011
Jkt 226001
2. FDA, ‘‘Cosmetic Labeling Manual,’’
available at https://www.fda.gov/
Cosmetics/CosmeticLabelingLabel
Claims/CosmeticLabelingManual/
default.htm.
3. FDA, ‘‘Guidance Documents,’’
available at https://www.fda.gov/
Cosmetics/GuidanceCompliance
RegulatoryInformation/Guidance
Documents/default.htm.
4. FDA, Bacteriological Analytical
Manual, chapter 23, ‘‘Microbiological
Methods for Cosmetics,’’ available at
https://www.fda.gov/Food/Science
Research/LaboratoryMethods/
BacteriologicalAnalyticalManualBAM/
ucm073598.htm.
VI. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://www.regulations.gov
and at FDA’s Web site under
‘‘Cosmetics.’’ It may also 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 the 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.
Dated: October 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–28238 Filed 10–31–11; 8:45 am]
BILLING CODE 4160–01–P
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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.
Notice of public workshop;
request for comments.
ACTION:
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.
E:\FR\FM\01NON1.SGM
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srobinson on DSK4SPTVN1PROD with NOTICES
67464
Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices
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:
https://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 https://www.adobe.com/
go/connectpro_overview. (FDA has
verified the Web site addresses in this
document, but FDA is not responsible
VerDate Mar<15>2010
17:04 Oct 31, 2011
Jkt 226001
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 https://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 https://
www.regulations.gov.
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.
SUPPLEMENTARY INFORMATION:
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.
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.
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III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
E:\FR\FM\01NON1.SGM
01NON1
Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices
accessible at https://
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
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0238]
Preventive Controls for Registered
Human Food and Animal Food/Feed
Facilities; Reopening of the Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening the
comment period for the notice,
published in the Federal Register of
May 23, 2011 (76 FR 29767), entitled
‘‘Preventive Controls for Registered
Human Food and Animal Food/Feed
Facilities; Request for Comments.’’ In
that document, FDA opened a docket
and requested information about
preventive controls and other practices
used by facilities to identify and address
hazards associated with specific types of
food and specific processes. The Agency
is taking this action in response to a
request for an extension to allow
interested persons additional time to
submit comments.
DATES: Submit either electronic or
written comments by December 20,
2011.
ADDRESSES: Submit electronic
comments to https://
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:04 Oct 31, 2011
Jkt 226001
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. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jenny Scott, Center for Food Safety and
Applied Nutrition (HFS–300), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, (240)
402–2166; or Kim Young, Center for
Veterinary Medicine (HFV–230), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, (240) 276–
9207.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 23,
2011 (76 FR 29767), FDA published a
notice with a 90-day comment period to
obtain information about preventive
controls and other practices used by
facilities to identify and address hazards
associated with specific types of food
and specific processes. Information
obtained will assist FDA in the
development of guidance on preventive
controls for food facilities that
manufacture, process, pack, or hold
human food or animal food/feed
(including pet food).
The Agency has received a request for
an extension of the comment period for
this notice. FDA has considered the
request and is extending the comment
period for the notice entitled
‘‘Preventive Controls for Registered
Human Food and Animal Food/Feed
Facilities; Request for Comments’’ until
December 20, 2011. The Agency
believes that this extension allows
adequate time for interested persons to
submit comments without significantly
delaying action by the Agency.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
Dated: October 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–28239 Filed 10–31–11; 8:45 am]
BILLING CODE 4160–01–P
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67465
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on Public Advisory
Panels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on certain device panels of the
Medical Devices Advisory Committee
(MDAC) in the Center for Devices and
Radiological Health (CDRH) notify FDA
in writing. FDA is also requesting
nominations for a nonvoting industry
representative(s) to serve on certain
device panels of the MDAC in the
CDRH. A nominee may either be selfnominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for current vacancies
effective with this notice.
DATES: Any industry organizations
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by December 1, 2011, for vacancies
listed in this notice. Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
December 1, 2011.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Margaret Ames (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5234, Silver Spring,
MD 20993, (301) 796–5960, Fax: (301)
847–8505, email:
margaret.ames@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
520(f)(3) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360j(f)(3)), as amended by the Medical
Device Amendments of 1976, provides
that each medical device panel include
one nonvoting member to represent the
interests of the medical device
SUMMARY:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
[[Page 67464]]
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: https://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 https://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 https://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 https://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
[[Page 67465]]
accessible at https://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
https://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
