2011-19353. 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.

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 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.