FDA Public Meeting on 510(k) Process is Today

The U.S. Food and Drug Administration (FDA) has planned a public meeting for today to discuss challenges related to premarket notification, or the 510(k) process, the agency said.

The FDA has convened an internal working group to review and improve upon the quality and consistency of the agency’s 510(k) process and administration of the program.

At the meeting, FDA staff will present an overview of the challenges the agency has faced:

• 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

• 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, and the meeting will close with a public roundtable discussion between agency staff and selected participants, according to the FDA.

“We are looking forward to hearing from the public on issues related to this program to help us improve it,” said Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.

The meeting will run from 8 a.m. to 5:30 p.m. at the Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, Md.

The meeting will be webcast live at www.ConnectLive.com/events/fda021810