FDA to examine medical device approval process

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FDA commissioned the Institute of Medicine (IOM) to comb through its premarket notification program, a procedure used to expedite certain medical device approvals, the agency announced today.

Additionally, an internal working group at FDA's Center for Devices and Radiological Health (CDRH) will begin a study tasked with evaluating and improving “the consistency of FDA decision making,” as it relates to the program.

Also known as the 510k process, the premarket notification program requires device manufacturers to notify FDA about their intent to market a medical device at least 90 days in advance, and can only be used for devices deemed equivalent to a previously approved device in one of three classification areas.

“Good government conducts periodic reviews and evaluations of its programs,” said Jeffrey Shuren, acting director of CDRH, in a statement. CDRH's former director, Daniel Schultz, resigned in August.

Almost a year ago, Reps. John Dingell (D-MI) and Bart Stupak (D-MI) launched an investigation into FDA's process for device review and approval, prompted by a letter from scientists employed in CDRH that charged the agency's management with corruption and interference in the review process of medical devices.

The $1.3 million IOM study is to be completed in 2011. As a part of the study, IOM will convene a committee to find out whether the current 510k process “optimally protect[s] patients and promote[s] innovation in the support of public health,” and if not, what actions can be taken to resolve the matter, according to the statement.

The three classifications for devices range from products with a high risk, such as heart valves and intraocular lenses (Class III), to lower risk devices in Class II or Class I, such as adhesive bandages or wheelchairs.

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