If the 510(k) clearance program for medical devices is the kind of thing that keeps you up at night, the Food and Drug Administration wants to hear from you.
The federal watchdog agency is planning a public meeting Feb. 18 to discuss the program, ahead of internal and external reviews of the process by which some 3,000 medical devices — the majority of the medical device clearance applications submitted to the FDA — are approved each year.
The 510(k) process is under scrutiny from within and without the agency, which is conducting its own review along with a $1.3 million, FDA-commissioned report from the Institute of Medicine. The public comment hearing will play a role in both reviews, according to an FDA press release.
Jeffrey Shuren, who recently had the “interim” tag removed from his title as director of the FDA’s Center for Devices and Radiological Health, said it’s been more than 30 years since the pre-market clearance program’s inception under the Medical Device Amendments of 1976.
"We are looking forward to hearing from the public on issues related to this program to help us improve it,” Shuren said.
The 510(k) program relies on so-called "predicate devices," or products the agency has already cleared. Device makers must prove that their new device is an advancement on similar devices the agency has already approved for market. Devices that are radically different must undergo the more rigorous, and expensive, PMA (pre-market approval) process.
The Feb. 18 meeting, slated for 8 a.m. to 5:30 p.m. in Gaithersburg, Md., will consist of four reviews of issues concerning the 510(k) process, each followed by are public comment period: predicate devices; new technologies and scientific evidence; the high volume of submissions; and post-market surveillance and reporting. The meeting, webcast live at http://www.ConnectLive.com/events/fda021810, will close with a "public roundtable discussion between FDA staff and selected participants representing a range of constituencies," according to the press release.