FDA to examine medical device approval process

Share this article:
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.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.