FDA Internal Review of 510(k) Program Launched

In response to increasing criticism toward the premarket approval process from the U.S. Congress and the public, who believe that the program may allow products on the market without adequate safety and effectiveness review, the U.S. Food and Drug Administration (FDA) has convened an internal working group to evaluate and improve the quality and consistency of the the agency's decision-making in the 510(k) program as well as its administration of the program.

The internal working group will hold its first public meeting on February 18, 2010. Presenters will provide a brief overview of the challenges the agency has faced, including issues related to:

• predicate devices, which are previously cleared devices that may support a manufacturer’s claim of substantial equivalence
• new technologies and scientific evidence
• practices the FDA has adopted in response to a high volume of submissions
• postmarket surveillance and new information about marketed devices

The public meeting will be held from 8:00 a.m. – 5:30 p.m. at the Hilton Washington DC/North Gaithersburg, in Gaithersburg MD. Registration is now open to those interested in attending or participating in the meeting. The deadline to register is 5:00 p.m. on February 12.

The meeting will also be Webcast live: visit www.ConnectLive.com/events/fda021810 on February 18.

For more information on the 510(k) program, please visit the FDA website