Panel Calls for More FDA Scrutiny of Medical Devices

A federal panel is urging the FDA to take a more detailed look at the approval process for medical devices. The recommendation comes in the wake of a spate of medical device recalls and failures in the past two years. The FDA has already taken some action regarding hip replacement medical devices after a rash of hip replacement failures and recalls that involved the DePuy ASR XL and DePux Pinnacle metal-on-metal hip devices.
The 12 member panel at the Institute of Medicine, a part of the National Academy of Sciences, is expected to carry significant weight and influence the FDA’s ultimate decision. The panel has recommended that the FDA review and revise its 510(k) review process under which the FDA approves medical devices without human studies if the device is “substantially equivalent” to others already on the market. That simpler approval process, known as a 510(k) approval, generally doesn’t evaluate the safety and effectiveness of a product in the way that is required for most drugs. This quicker approval process has led to criticism and resulted in device failures and recalls in the last few years.