The U.S. Food and Drug Administration (FDA) should scrap its current oversight strategy for medical devices and, with legislation from Congress if needed, create a new system to ensure that devices are safe and effective. That's the bottom line of a 246-page report from the Institute of Medicine (IOM) that was released today.
Since 1976, FDA has relied on what's called the "501(k) clearance process." It permits new devices on the market if the maker can prove they're "substantially equivalent" to devices already out there, in contrast to new drug applications, which generally get more stringent vetting. But in the last several years, a number of dangerous devices have sparked concern, including surgical mesh linked to infection and faulty artificial hips. In 2009, FDA asked IOM to review the way it handles medical devices.
The results are clear: In a press release, IOM said the 501(k) process "lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk" devices. (High-risk devices get additional review.) The institute also urged FDA to improve its postmarketing surveillance of devices, to catch problems that may not have been obvious before approval.
What's next isn't clear. But in an unusual report in The New York Times earlier this week, Barry Meier described an "extraordinary campaign" by allies of the medical device industry to discredit the report. FDA says it will be accepting public comments on the report, to help it determine what to do next.