FDA Chief to Review Medical Device Approval Process

U.S. Food and Drug Administration Commissioner Margaret Hamburg recently told lawmakers that she wants to take a good look at the agency’s medical device division.

She said she will look into the division’s 510(k) regulatory approval process for devices. Earlier this year, agency scientists have said some companies should have been required to show more data on safety and efficacy.

Former FDA Commissioner David Kessler, who described the device center as “dysfunctional” and “in meltdown,” said he has discussed the crisis at the device center with Hamburg.

The Advanced Medical Technology Association (AdvaMed), the Washington lobbying group for the device industry based in Washington, D.C., doesn’t think the regulatory process needs fixing.

“The current system for medical device regulation is fundamentally sound and gives FDA the flexibility it needs,” said Janet Trunzo, an executive vice president at AdvaMed.

An editorial (see http://content.nejm.org/cgi/content/full/360/24/2493 ) appeared in the New England Journal of Medicine on June 11, co-authored by Hamburg and chief deputy Joshua Sharfstein, arguing that the main mission of the FDA is to be a public health agency.

Hamburg will be the closing keynote speaker at the 2009 Annual Conference of the Regulatory Affairs Professionals Society (RAPS) Sept. 19 at the Pennsylvania Convention Center in Philadelphia, Pa. For more information, visit www.raps.org.