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Dive Brief: FDA has cleared 53 testing laboratories to participate in its Accreditation Scheme for Conformity Assessment (ASCA) pilot, a voluntary program for medical device safety and performance testing. The ASCA-accredited laboratories will assess whether medical devices conform to consensus standards. FDA created the program to make conformity testing more consistent for device manufacturers undergoing 510(k) premarket notification and other regulatory reviews. So far, none of the laboratories, which include sites run by TÜV SÜD and UL, have received accreditation for biocompatibility testing. FDA plans to accredit more laboratories. Dive Insight: FDA finalized its guidance on ASCA last year after the release of draft documents in 2019 prompted calls for greater clarity. The finalization of the guidance positioned the agency to build a list of laboratories to put the pilot program into practice. The ASCA pilot accreditation program will allow independent ....