2010-4662. Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA) is extending to March 19, 2010, the comment period for the notice that appeared in the Federal Register of Wednesday, January 27, 2010 (75 FR 4402). In the notice, FDA requested comments on a number of identified challenges associated with the 510(k) process. The agency is taking this action to allow interested persons additional time to submit comments.

DATES:

Submit written or electronic comments and information by March 19, 2010.

ADDRESSES:

Submit written comments or information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments or information to http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1609, Silver Spring, MD 20993, 301-796-6313, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 27, 2010 (75 FR 4402), FDA published a notice announcing a public meeting on February 18, 2010, and the opening of a public docket to receive comments on key challenges related to the premarket notification (or 510(k)) process for the review of medical devices. Specific questions for comment were listed and interested persons were invited to submit comments by March 5, 2010. At this time, the agency is extending the comment period until March 19, 2010, to continue to receive public comments. Comments submitted to the docket will assist in identifying actions that the Center for Devices and Radiological Health can consider taking to strengthen the 510(k) process.

II. Submission of Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. All comments submitted to the public docket are public information and may be posted to FDA's Web site at http://www.fda.gov for public viewing. Comments are to be identified with the docket number found in brackets in the heading of this document. In addition, when responding to specific questions as outlined in the Federal Register of January 27, 2010, 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.

Dated: March 1, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.