FDA Seeks Comment on Device Detention Rules
The FDA proposes to renew the inspection protocols for banned medical devices and is seeking more - make that any - comment from the public.
Having pursued less than 1 device detention annually over the past several years, the FDA is proposing once again to extend and renew the program that collects information about medical devices, submitting the proposed changes to the Office of Management & Budget for approval.
Last year, the FDA asked the public for more information about risky or harmful devices but didn't receive a single comment. The watchdog agency is now extending the information-gathering procedures for banning a device.