DeLauro Statement on GAO Review of FDA’s Approval Process for Medical Device

Washington, DC – Congresswoman Rosa L. DeLauro (Conn. -3) issued the following statement on the report issued by the Government Accountability Office: "FDA Should Take Steps to Ensure that High Risk Device Types are Approved Through the Most Stringent Premarket Review Process," which found that the agency approved higher-risk medical devices using a process intended for low-risk products.

"The GAO report is yet another confirmation that the 510(k) medical device approval process at FDA has become distorted. What once was a sensible approach to approve new products that are ‘substantially equivalent' to existing low-risk devices, the 510(k) seems to have been transformed into a process that includes even potentially life-saving and life-threatening devices. This poses unacceptable risks to the public health.

"Patients seeking accurate diagnosis and effective treatment may be harmed by the FDA's failure to be guided by its own scientists involving decisions on medical devices. In order to protect the public health, the FDA must use the 510(k) process as the law intended – only for low-risk devices that are very similar to others on the market. The FDA also must rely on independent scientific review, and prohibit political and corporate influence on scientific decisions."