DeLauro Slams FDA Medical Device Approval Process

Press Release

Congresswoman Rosa DeLauro (CT-3), Ranking Member on the Labor, Health, and Human Services Appropriations Subcommittee, issued the following statement in response to a study released today by the Archives of Internal Medicine showing the Food and Drug Administration (FDA)'s medical device approval process to be flawed.

The study examined all medical devices that FDA determined to be potentially life threatening or could cause serious permanent harm and were recalled from 2005 to 2009. Of those 113 recalls, 71% of the devices were approved through the 510(k) provision, which requires only that a new device be similar to an already marketed product, and does not require clinical trials or manufacturing facility inspections.

"I am seriously alarmed by the findings in this report, which indicate that 510(k) medical devices approval process used by FDA does not adequately test medical devices to ensure patients' safety. This process has evolved from a sensible approach to approving low-risk, very similar devices into a process that includes even life-saving and life-threatening devices, and is no longer acceptable. This study demonstrates once and for all that FDA should resist pressure from industry to reform this process, and instead rely on strong scientific analysis to approve all medical devices."

Source