The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that with a new set of Medical Device User Fee Amendments (MDUFA IV) making their way through Congress, the Food and Drug Administration (FDA) is getting a jump-start on a plan to recognize accredited testing laboratories. Under this scheme, the agency would use reports from these laboratories during premarket reviews as evidence of conformity to recognized standards by manufacturers. The agency is asking for feedback on its proposal, which it outlined in a Federal Register notice published May 16. Under the current system, medical device manufacturers can include a “Declaration of Conformity” to identify which voluntary consensus standards they used in their application to meet premarket requirements for their devices. According to the FDA, this system “has not been consistently applied by sponsors in submissions,” causing “challenges for manufacturers and FDA alike.”
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