Accreditation Scheme for Conformity Assessment (ASCA)Accreditation Scheme for Conformity Assessment (ASCA)

https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/accreditation-scheme-conformity-assessment-asca?utm_medium=email&utm_source=govdelivery The Accreditation Scheme for Conformity Assessment (ASCA) is a voluntary accreditation program that capitalizes on the increasingly prominent role of consensus standards in regulatory science. Effective today, the U.S. Food and Drug Administration’s ASCA program is converting from a pilot to a permanent program. This transition is authorized by the Medical Device User Fee Amendments of 2022 (MDUFA V). The ASCA program’s goals are to: Streamline conformity assessment in medical device submissions Enhance the FDA’s confidence in test methods and results Decrease the need for additional information related to conformance with a standard Promote consistency, predictability, and efficiency in medical device review Serve as a least burdensome approach to conformity assessment