FDA Moves to Expel Three Defunct Devices

Three medical devices face removal from the market if their manufacturers fail to file applications for premarket approval with the FDA by Nov. 21. But the Aug. 16 ruling is essentially moot because the affected devices—a ventricular-assist device, various pacemaker repair products and a version of the female condom—are out of date. “These three device types are no longer being marketed, and have in fact been replaced by newer technology regulated under different classifications, so we expect this rule to have little to no impact on industry,” FDA press officer Erica Jefferson told Healthcare Technology Management.