FDA Sets Hearing To Discuss Medical Device Approvals

The U.S. Food and Drug Administration just announced a public meeting, to be held on February 18, 2010, to discuss key challenges related to pre-market notification, or the 510(k) process, used to review and clear certain <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions annually.

As we have previously written and the Associated Press (AP) noted last year, scientists under former medical device head, Daniel Schultz, claimed, “they were pressured to approve certain products” against their best judgment. It was a nine-scientist letter that added to the call for reform at the agency. Following the letter, a number of lawmakers called on the FDA to investigate the alleged corruption, reported the AP. Schultz who managed the division for five years, ultimately resigned, said the AP.

Earlier last year we wrote that many critics of the U.S. Food and Drug Administration (FDA) had long complained of safety problems, corruption, conflicts of interest, and budgeting and system problems that appeared to be routine at the agency under the former administration. With the Obama administration, new leaders were put in place and safety became an issue of importance at the FDA.

The public notice for the meeting is scheduled to appear in the January 27, 2010 Federal Register. The agency announced it had asked the Institute of Medicine (IOM) to conduct a comprehensive study of the process. That request was made in September; the IOM study is expected to conclude next March.

In the interim, the FDA convened an internal working group to evaluate and improve the quality and consistency of its decision-making in the 510(k) process as well as its program administration. “It’s been more than 30 years since the establishment of the pre-market notification process for medical devices,” said Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We are looking forward to hearing from the public on issues related to this program to help us improve it.”

At the meeting, FDA staff will present a brief overview of the challenges the agency has faced, 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 adopted in response to a high volume of submissions; and issues related to post-market surveillance and new information about marketed devices. An open comment session will follow the presentation and a public roundtable between agency staff and specific participants will conclude the meeting, which will run from 8:00 a.m. to 5:30 p.m. at the Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, Maryland. Those interested in attending or participating must register by 5:00 p.m. on February 12, 2010; written or electronic comments will be accepted until March 5, 2010.

A live Webcast of the meeting can be accessed at http://www.ConnectLive.com/events/fda021810.

The FDA classifies medical devices into three categories, by risk, with Class III representing the highest risk level and generally requiring pre-market approval to support safety and efficacy. Class III devices include heart valves and intraocular lenses. Class I and II devices pose lower risks and include adhesive bandages and wheelchairs.

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