WHAT: An Institute of Medicine commission hired by the Food and Drug Administration to improve its system for approving medical devices such as pacemakers and implants said the whole 35-year-old process should be dumped because it doesn’t protect patients.
WHY: Unlike new prescription drugs, only a handful of truly new devices get costly human testing to prove they are safe and effective. The FDA just makes most medical devices show that they are not too similar to other devices already on the market.
WHAT WAS RECOMMENDED: The nonpolitical medical experts said the FDA should develop a new system based on known safety standards and tracking device failure rates in the real world. This could replace most premarket testing, which is unfeasible for every new device.