FDA’s ‘flawed’ device pathway persists with industry backing

WASHINGTON (AP) — The Food and Drug Administration clears roughly 3,000 medical devices every year through a system that generally requires little or no patient testing to verify safety and effectiveness.
Unlike new pharmaceuticals, most medical devices are approved based on similarities to already-approved devices, not specific clinical trial testing.
The streamlined system for devices has been blamed for a string of dangerous devices reaching US patients, including defective hip replacem