USA – US FDA ASCA Program: How the new Accreditation Scheme for Conformity Assessment pilot will work for medical device premarket reviews

The US Food and Drug Administration recently issued final guidance for its highly anticipated Accreditation Scheme for Conformity Assessment (ASCA) pilot, effectively launching the program and setting application deadlines for accredited body and testing laboratory applicants.

FDA has also published a flowchart explaining the steps involved in the ASCA process, and how the program will provide more consistent and streamlined premarket reviews for medical device manufacturers…