DeLauro Calls for Safer Medical Device Approval Process

Washington, DC— Congresswoman Rosa DeLauro (CT-3), Ranking Member of the Appropriations Subcommittee on Labor, Health and Human Services, Education, issued the following statement today in response to the FDA's announcement of a new plan for bringing medical devices to the marketplace.

"Today's announcement by FDA on reforming the 510(k) medical device approval process is very disappointing, as it would appear that the agency is avoiding implementing certain recommendations due to industry concerns. While I agree that safe and effective medical devices should be brought to market as soon as possible, the emphasis needs to be on the ‘safe and effective' part of this equation. If the FDA is going to improve safety standards for medical devices, it should do so based on strong scientific evidence and not industry popularity."