FDA Seeks to Streamline Device Unit

The new head of the U.S. Food and Drug Administration says she is working to clean up the agency's troubled device unit, including a review of how it approves medical devices.

She says the device unit was "clearly troubled" and it was immediately clear to her that big changes were in order. "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," FDA Commissioner Margaret Hamburg states.

Hamburg, who took the helm of the FDA in May, says the agency is in the process of hiring a new head for the device unit. She declined to say when that person would be named.

She says a formal review of the 510(k) process - which is used for reviewing most medical devices approved by the agency such as sutures and intravenous administration sets and is less stringent than the FDA's pre-market approval process used in reviewing high-risk devices - was under way.

Hamburg says she had heard from people in the medical device industry, from medical groups and medical professions, who were complaining about the confusing nature of some of the system's requirements.

"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 states.

The Institute of Medicine is studying the 510(k) process. The results will not be available until March 2011.

Michael Mussallem, chairman of the trade group Advanced Medical Technology Association, told the Reuters Summit the industry did not object to 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," says Mussallem, who is chief executive of Edwards Lifesciences.