[Federal Register Volume 75, Number 43 (Friday, March 5, 2010)]
[Notices]
[Pages 10294-10295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4662]
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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: [email protected].
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]
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