FDA to Re-Assess Premarket Clearance for Medical Devices

January 25, 2010 - With more than 3,000 requests for medical devices to get 510(k) clearance each year, the U.S. Food and Drug Administration (FDA) asked the Institute of Medicine (IOM) to conduct a comprehensive study of the process, which is not scheduled to be concluded for another year.

In the meantime, the FDA is internally evaluating the quality and consistency in the 510(k) process. To garner public feedback on the matter, the FDA 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 medical devices marketed in the United States.

The agency established the premarket notification process for medical devices 30 years ago, and now is holding a hearing on the process of approving medical devices, noted Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.

The FDA staff will highlight issues with previously cleared devices that may support a manufacturer’s claim of substantial equivalence; challenges with assessing new technologies and scientific evidence; managing the high volume of submissions; and 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 be held on February 18,. 2010, meeting will run from 8 a.m. to 5:30 p.m. at the Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, Md. To attend or participate in the meeting you must register by 5 p.m. on Feb. 12, 2010. The agency is accepting written or electronic comments by March 5, 2010.

For more information: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm183497.htm