FDA Public Meeting on Premarket Clearance Process for Medical Devices
The U.S. Food and Drug Administration 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. At the meeting, FDA staff will present a brief overview of the challenges the agency has faced, organized in four categories: issues related to predicate devices, which are previously cleared devices that may support a manufacturer’s claim of substantial equivalence; issues related to new technologies and scientific evidence; issues related to practices the FDA has adopted in response to a high volume of submissions; and issues related to postmarket surveillance and new information about marketed devices. Each of the four overview presentations will be followed by an open comment session. The meeting will close with a public roundtable discussion between FDA staff and selected participants representing a range of constituencies.