Document ID: FDA-2010-N-0054-0009
Agency: fda
Document Type: Notice
Title: Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension of Comment Period
Posted Date: 2010-03-05T05:00Z

[Federal Register: March 5, 2010 (Volume 75, Number 43)]
[Notices]               
[Page 10294-10295]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr10-95]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0054]

 
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.

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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: james.swink@fda.hhs.gov.

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,

[[Page 10295]]

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.
[FR Doc. 2010-4662 Filed 3-4-10; 8:45 am]
BILLING CODE 4160-01-S