FDA Takes Steps Toward Creating Lab Accreditation System For Evaluating Medical Devices

FDA took a step Monday (May 15) toward setting up a system to more fully rely on accredited testing laboratories to evaluate medical devices according to FDA-recognized standards -- a goal that came out of the most recent talks between the agency and industry on the Medical Device User Fee Amendments (MDUFA). In a Monday notice the agency asked for public input on how to design its Accreditation Scheme for Conformity Assessment (ASCA) pilot program, including what consensus standards must...