Hamburg looks to clean house at CDRH

November 13, 2009 by MassDevice staff

Food & Drug Administration commissioner Margaret Hamburg plans to clean up the mess at its "clearly troubled" Center for Devices and Radiological Health.

Scarcely seven months into her tenure as commissioner of the Food & Drug Administration, Margaret Hamburg is vowing to clean up the agency's "clearly troubled" Center for Devices and Radiological Health.

Hamburg told attendees at the Reuters Health Summit in New York that it was immediately apparent to her that CDRH needed a drastic overhaul, according to the news service.

"We are working on some important issues that will benefit industry and benefit the ultimate outcome of our regulatory procedures, including making sure we have a robust internal review process," Hamburg said.

Shortly after taking the job, Hamburg signaled that a new era was under way, promising that the agency would be faster and more aggressive under her leadership. The watchdog agency, which is in the process of hiring a new CDRH head, tapped the Institute of Medicine to run a soup-to-nuts review of its 510(k) clearance process, the route by which the majority of medical devices are approved. The review comes after Hamburg heard complaints from the medical device industry that the 510(k) clearance system is confusing and unwieldy, according to Reuters.

"And I was hearing from investors that unless there was a more explicit definition of standards and expectations, that it was increasingly unattractive to them to be investing in the medical device area," she said.

AdvaMed chairman and Edwards Lifescience CEO Michael Mussallem said at the summit that his industry is fine with the review.

"There have been some questions raised about the appropriateness of the approvals of medical devices, and that's going to get a hard look. That's fine, it should," Mussallem said.