February 18, 2010 - FDA 510(k) Process For Medical Devices

The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.

The public notice for the meeting will appear in the Jan. 27, 2010 Federal Register.

The Feb. 18 meeting will run from 8 a.m. to 5:30 p.m. at the Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, Md. Those interested in attending or participating in the meeting must register by 5 p.m. on Feb. 12, 2010. The agency is accepting written or electronic comments by March 5, 2010.

The meeting will be Webcast live at http://www.ConnectLive.com/events/fda021810 (link not active yet).