[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45825-45826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19353]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0556]
Center for Devices and Radiological Health 510(k) Clearance
Process; Institute of Medicine Report: ``Medical Devices and the
Public's Health, The FDA 510(k) Clearance Process at 35 Years;''
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is requesting comments
on the Institute of Medicine (IOM) report entitled: ``Medical Devices
and the Public's Health, The FDA 510(k) Clearance Process at 35
Years.'' The establishment of this public docket does
[[Page 45826]]
not signify FDA endorsement or concurrence with any of the conclusions
or recommendations contained within the report. FDA may, in the future,
take additional measures to solicit public input in the report and
specific recommendations contained therein. FDA will not adopt any of
the recommendations contained in the report before the close of this
comment period.
DATES: Submit either electronic or written comments on the report by
September 30, 2011.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic
access to the document. Submit electronic comments on the preliminary
report 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. 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. 5452, Silver Spring, MD 20993-0002, 301-
796-5678.
SUPPLEMENTARY INFORMATION:
I. Background
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 first prong of this evaluation consisted of an internal
evaluation of the 510(k) process, resulting in the publication of the
CDRH preliminary internal evaluation entitled: ``510(k) Working Group
Preliminary Report and Recommendations'' (http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220784.pdf). This
preliminary report was intended to communicate preliminary findings and
recommendations regarding the 510(k) program and actions CDRH might
take to address identified areas of concern. The report was issued on
August 5, 2010 (75 FR 47307). After reviewing public comment, CDRH
issued a plan of action for implementation of the previously announced
recommendations on January 19, 2011 (http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239450.pdf).
The second prong of the comprehensive assessment of the 510(k)
process was an independent study by the IOM. At the request of FDA, IOM
has evaluated the 510(k) clearance process and made recommendations
aimed at protecting the health of the public and making available a
mechanism to achieve timely access of medial devices to the market. On
July 29, 2011, IOM released the report ``Medical Devices and the
Public's Health, The FDA 510(k) Clearance Process at 35 Years.'' While
FDA has not yet had the opportunity to fully evaluate this report, the
agency does recognize the strong public interest in the comprehensive
assessment of the 510(k) process and the IOM report. For this reason,
FDA is opening a public docket and requesting public comment on the
report. The establishment of this public docket does not signify agency
endorsement or concurrence with any of the conclusions or
recommendations contained within the report. FDA may, in the future,
take additional measures to solicit public input in the report and
specific recommendations contained therein. FDA will not adopt any of
the recommendations contained in the report before the close of this
comment period.
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
The IOM report entitled: ``Medical Devices and the Public's Health,
The FDA 510(k) Clearance Process at 35 Years'' can be obtained from the
IOM Web site at http://www.iom.edu/Activities/PublicHealth/510KProcess.aspx.
Dated: July 26, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19353 Filed 7-29-11; 8:45 am]
BILLING CODE 4160-01-P