The U.S. Food and Drug Administration (FDA) has announced in the Federal Register that it is extending the period for comments on the identified challenges associated with the 510(K) process review of medical devices. Originally, the comment period was March 5. The new deadline is March 19. Comments submitted, the FDA says, "will assist in identifying actions that the Center for Devices and Radiological Health can consider taking to strengthen the 510(k) process."

The comment period follows the public meeting in February on challenges related to the pre-market notification process for the review of medical devices. A notice in the Federal Register on January 27 requested comments on the identified challenges. Written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Electronic comments or information to http://www.regulations.gov. Comments should be identified with the Docket Number FDA-2010-N-0054.

If responding to specific questions in the January Federal Register notice, the particular question should be identified. The January Federal Register can be found through the Government Printing Office Web site or http://www.regulations.gov with the same Docket number. The questions for discussion relate to predicate devices, new technologies and scientific evidence, practices the Center for Devices and Radiological Health (CDRH) has adopted in response to a high volume of 510(K) submissions, and issues related to post-market surveillance and new information about marketed devices.
The current Federal Register Notice can be accessed at: http://edocket.access.gpo.gov/2010/2010-4662.htm

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