Document ID: FDA-2011-N-0556-0001
Agency: fda
Document Type: Notice
Title: Institute of Medicine Report; Availability: Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years
Posted Date: 2011-08-01T04:00Z

[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45825-45826]
From the Federal Register Online via the Government Printing 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