Federal health regulators asked the country’s leading medical experts two years ago to recommend ways to improve the government’s system for approving most medical devices, ranging from pacemakers to X-ray scanners. On Friday the experts came back with a surprise answer: scrap it because it fails to protect patients. Even more surprising, FDA summarily dismissed the idea.

The Institute of Medicine’s panel said in a report that the U.S. government should abandon the 35-year-old system used to clear medical devices because it provides little assurance that the implants are actually safe. The 12-member group’s advice, commissioned by the Food and Drug Administration, is not binding. And experts questioned its real-world impact after the FDA immediately distanced itself from the advice it had requested.
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