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