The US Food and Drug Administration (FDA) has issued its first set of draft guidance documents for the full-fledged Accreditation Scheme for Conformity Assessment (ASCA) program following the completion of its pilot phase.
The three draft guidances, which replace the final guidances released by the agency in September 2020, propose improvements to the ASCA program based on feedback from the pilot program as well as demonstrate the agency’s commitments outlined in Medical Device User Fee Amendments 2022 (MDUFA V).
“These draft guidance updates incorporate feedback received through public meetings and webinars, the docket, stakeholder meetings, communications with participating accreditation bodies and testing laboratories, and lessons learned internally from review staff and ASCA staff during the pilot phase,” FDA wrote in a Federal Register notice. “The updates will also allow FDA to appropriately expand ASCA per MDUFA V commitments and expectations.”…
