Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, and Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations; Availability; Request for Comments, 47307-47308 [2010-19339]
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Federal Register / Vol. 75, No. 150 / Thursday, August 5, 2010 / Notices
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[FR Doc. 2010–19268 Filed 8–4–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0348]
Center for Devices and Radiological
Health 510(k) Working Group
Preliminary Report and
Recommendations, and Task Force on
the Utilization of Science in Regulatory
Decision Making Preliminary Report
and Recommendations; Availability;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comment.
The Food and Drug
Administration (FDA) is announcing the
availability for public comment of a
two-volume set of documents entitled
‘‘Center for Devices and Radiological
Health Preliminary Internal
Evaluations,’’ which is comprised of the
preliminary reports of two internal
committees: The 510(k) Working Group
and the Task Force on the Utilization of
Science in Regulatory Decision Making.
Volume I is entitled ‘‘510(k) Working
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:52 Aug 04, 2010
Jkt 220001
Group Preliminary Report and
Recommendations.’’ Volume II is
entitled ‘‘Task Force on the Utilization
of Science in Regulatory Decision
Making Preliminary Report and
Recommendations.’’ The
recommendations contained in these
reports are preliminary. FDA has not
made any decisions on specific changes
to pursue. FDA is soliciting public input
on the recommendations discussed in
these reports, including the feasibility of
implementation and potential
alternatives. Once its assessment of
public input and other necessary
reviews are completed, FDA will
announce which improvements it will
implement, as well as projected
timelines for implementation.
DATES: Submit either electronic or
written comments on the preliminary
report by October 4, 2010.
ADDRESSES: See the SUPPLEMENTARY
INFORMATION section for electronic
access to the document.
Submit electronic comments on the
preliminary report 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. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5447, Silver Spring,
MD 20993–0002, 301–796–5678.
SUPPLEMENTARY INFORMATION:
I. Background
A. 510(k) Working Group
The premarket notification (510(k))
process for the review of medical
devices was established in 1976, under
the Medical Device Amendments to the
Federal Food, Drug, and Cosmetic Act
(FDCA). With the exception of certain
low-risk devices that are exempt from
premarket submission requirements, a
medical device that is first introduced
into the market after May 28, 1976 (a
postamendment device) may be legally
marketed without an approved
premarket approval application (PMA)
if FDA concludes through review of a
510(k) submission that the device meets
the comparative standard of ‘‘substantial
equivalence’’ to a ‘‘predicate’’ device.
Substantial equivalence may be
determined by a comparison to a device
that was legally marketed prior to May
28, 1976 (a preamendment device), to a
device that has been reclassified from
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
47307
class III (high-risk) to class II or class I
(medium- to low-risk), or to a device
that has previously been cleared
through the 510(k) process.
Since its inception, the 510(k) process
has undergone a number of statutory
changes. In addition, FDA has modified
its implementation of the process to
adapt to changing circumstances and
accommodate the evolving medical
device landscape. The current 510(k)
program reflects the current statutory
framework and FDA’s implementation
of that framework through regulation,
guidance, and administrative practice.
The 510(k) program, as it currently
exists, is intended to support FDA’s
public health mission by meeting two
important goals: making available to
consumers devices that are safe and
effective, and fostering innovation in the
medical device industry. In recent years,
concerns have been raised within and
outside of FDA about whether the
current 510(k) program optimally
achieves these goals.
In September 2009, CDRH convened
an internal 510(k) Working Group as
part of a two-pronged, comprehensive
assessment of the 510(k) process. The
other component of this assessment is
an ongoing independent study by the
Institute of Medicine, which is expected
to conclude in the summer of 2011. The
510(k) Working Group was charged to
evaluate the 510(k) program and explore
actions CDRH could take to strengthen
the program and improve the
consistency of its decision making, with
a principal focus on actions the Center
could take in the short term under its
existing statutory authority.
B. Task Force on the Utilization of
Science in Regulatory Decision Making
CDRH uses science to guide its
regulatory decision making across the
total product life cycle of medical
devices and radiation-emitting products.
At any stage of that life cycle, CDRH
may encounter new, unfamiliar, or
unexpected information that may
influence its thinking, expectations, and
actions. To fulfill its mission to protect
and promote the public health, CDRH
must strike a balance between the
ability to adapt its approach as
necessary as new science emerges, and
the desire to provide predictable
regulatory pathways that foster
innovation.
In September 2009, CDRH convened
an internal Task Force on the Utilization
of Science in Regulatory Decision
Making to review how CDRH uses
science in its regulatory decision
making, and to make recommendations
on how the Center can quickly
incorporate new science—including
E:\FR\FM\05AUN1.SGM
05AUN1
47308
Federal Register / Vol. 75, No. 150 / Thursday, August 5, 2010 / Notices
evolving information, novel
technologies, and new scientific
methods—into its decision making,
while also maintaining as much
predictability as practical.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
C. Preliminary Reports
FDA is making available for public
comment a two-volume set of
documents entitled ‘‘Center for Devices
and Radiological Health Preliminary
Internal Evaluations.’’ Volume I is
entitled ‘‘510(k) Working Group
Preliminary Report and
Recommendations.’’ This preliminary
report is intended to communicate
preliminary findings and
recommendations regarding the 510(k)
program and actions CDRH might take
to address identified areas of concern.
Volume II is entitled ‘‘Task Force on the
Utilization of Science in Regulatory
Decision Making Preliminary Report
and Recommendations.’’ This
preliminary report is intended to
communicate preliminary findings and
recommendations regarding the
incorporation of new scientific
information into CDRH’s decision
making and actions CDRH might take to
address identified areas of concern.
Interested persons are invited to
comment on either or both of these
preliminary reports. CDRH will consider
comments received prior to finalizing
the two reports and determining which,
if any, recommendations to implement
in their current or a modified form.
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.
mstockstill on DSKH9S0YB1PROD with NOTICES
III. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.regulations.gov or https://
www.fda.gov/AboutFDA/CentersOffices/
CDRH/CDRHReports/default.htm (select
appropriate option from the menu).
Dated: July 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–19339 Filed 8–4–10; 8:45 am]
BILLING CODE 4160–01–S
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Tobacco Products Scientific Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Tobacco
Products Scientific Advisory Committee
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on August 30, 2010, from 8:30 a.m.
to 12 noon.
Location: Gaithersburg Marriott
Washingtonian Center, 9751
Washingtonian Blvd., Gaithersburg, MD.
The hotel telephone number is 301–
590–0044.
Contact Person: Cristi Stark, Center
for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 1–877–287–1373
(choose option 4), e-mail:
TPSAC@fda.hhs.gov or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
8732110002. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On August 30, 2010, the
committee will receive a report from the
Tobacco Product Constituents
Subcommittee and discuss a proposed
initial list of harmful or potentially
harmful constituents, the rationale for
inclusion of each constituent,
established analytical methods as well
as the ancillary methods and
normalization standards for the
identified constituents.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
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material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 23, 2010.
Oral presentations from the public will
be scheduled between approximately 10
a.m. and 11 a.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 13, 2010. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 16, 2010.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Cristi Stark
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
E:\FR\FM\05AUN1.SGM
05AUN1
]]>Agencies
[Federal Register Volume 75, Number 150 (Thursday, August 5, 2010)]
[Notices]
[Pages 47307-47308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19339]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0348]
Center for Devices and Radiological Health 510(k) Working Group
Preliminary Report and Recommendations, and Task Force on the
Utilization of Science in Regulatory Decision Making Preliminary Report
and Recommendations; Availability; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for public comment of a two-volume set of documents
entitled ``Center for Devices and Radiological Health Preliminary
Internal Evaluations,'' which is comprised of the preliminary reports
of two internal committees: The 510(k) Working Group and the Task Force
on the Utilization of Science in Regulatory Decision Making. Volume I
is entitled ``510(k) Working Group Preliminary Report and
Recommendations.'' Volume II is entitled ``Task Force on the
Utilization of Science in Regulatory Decision Making Preliminary Report
and Recommendations.'' The recommendations contained in these reports
are preliminary. FDA has not made any decisions on specific changes to
pursue. FDA is soliciting public input on the recommendations discussed
in these reports, including the feasibility of implementation and
potential alternatives. Once its assessment of public input and other
necessary reviews are completed, FDA will announce which improvements
it will implement, as well as projected timelines for implementation.
DATES: Submit either electronic or written comments on the preliminary
report by October 4, 2010.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic
access to the document.
Submit electronic comments on the preliminary report 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. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5447, Silver Spring, MD 20993-0002, 301-
796-5678.
SUPPLEMENTARY INFORMATION:
I. Background
A. 510(k) Working Group
The premarket notification (510(k)) process for the review of
medical devices was established in 1976, under the Medical Device
Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA). With the
exception of certain low-risk devices that are exempt from premarket
submission requirements, a medical device that is first introduced into
the market after May 28, 1976 (a postamendment device) may be legally
marketed without an approved premarket approval application (PMA) if
FDA concludes through review of a 510(k) submission that the device
meets the comparative standard of ``substantial equivalence'' to a
``predicate'' device. Substantial equivalence may be determined by a
comparison to a device that was legally marketed prior to May 28, 1976
(a preamendment device), to a device that has been reclassified from
class III (high-risk) to class II or class I (medium- to low-risk), or
to a device that has previously been cleared through the 510(k)
process.
Since its inception, the 510(k) process has undergone a number of
statutory changes. In addition, FDA has modified its implementation of
the process to adapt to changing circumstances and accommodate the
evolving medical device landscape. The current 510(k) program reflects
the current statutory framework and FDA's implementation of that
framework through regulation, guidance, and administrative practice.
The 510(k) program, as it currently exists, is intended to support
FDA's public health mission by meeting two important goals: making
available to consumers devices that are safe and effective, and
fostering innovation in the medical device industry. In recent years,
concerns have been raised within and outside of FDA about whether the
current 510(k) program optimally achieves these goals.
In September 2009, CDRH convened an internal 510(k) Working Group
as part of a two-pronged, comprehensive assessment of the 510(k)
process. The other component of this assessment is an ongoing
independent study by the Institute of Medicine, which is expected to
conclude in the summer of 2011. The 510(k) Working Group was charged to
evaluate the 510(k) program and explore actions CDRH could take to
strengthen the program and improve the consistency of its decision
making, with a principal focus on actions the Center could take in the
short term under its existing statutory authority.
B. Task Force on the Utilization of Science in Regulatory Decision
Making
CDRH uses science to guide its regulatory decision making across
the total product life cycle of medical devices and radiation-emitting
products. At any stage of that life cycle, CDRH may encounter new,
unfamiliar, or unexpected information that may influence its thinking,
expectations, and actions. To fulfill its mission to protect and
promote the public health, CDRH must strike a balance between the
ability to adapt its approach as necessary as new science emerges, and
the desire to provide predictable regulatory pathways that foster
innovation.
In September 2009, CDRH convened an internal Task Force on the
Utilization of Science in Regulatory Decision Making to review how CDRH
uses science in its regulatory decision making, and to make
recommendations on how the Center can quickly incorporate new science--
including
[[Page 47308]]
evolving information, novel technologies, and new scientific methods--
into its decision making, while also maintaining as much predictability
as practical.
C. Preliminary Reports
FDA is making available for public comment a two-volume set of
documents entitled ``Center for Devices and Radiological Health
Preliminary Internal Evaluations.'' Volume I is entitled ``510(k)
Working Group Preliminary Report and Recommendations.'' This
preliminary report is intended to communicate preliminary findings and
recommendations regarding the 510(k) program and actions CDRH might
take to address identified areas of concern. Volume II is entitled
``Task Force on the Utilization of Science in Regulatory Decision
Making Preliminary Report and Recommendations.'' This preliminary
report is intended to communicate preliminary findings and
recommendations regarding the incorporation of new scientific
information into CDRH's decision making and actions CDRH might take to
address identified areas of concern.
Interested persons are invited to comment on either or both of
these preliminary reports. CDRH will consider comments received prior
to finalizing the two reports and determining which, if any,
recommendations to implement in their current or a modified form.
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.
III. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.regulations.gov or https://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/default.htm (select appropriate option
from the menu).
Dated: July 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19339 Filed 8-4-10; 8:45 am]
BILLING CODE 4160-01-S
