Effective September 19, 2023, 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 will continue to be implemented through the final guidance documents.
The voluntary ASCA Program is an accreditation scheme that capitalizes upon the increasingly prominent role that standards play in regulatory science and practice. ASCA’s goals are to:
- Streamline conformity assessment in 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
Takeaway: The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions, as conformity to relevant standards both reduces regulatory burden and fosters quality
If you would like to receive notifications about ASCA, email: info@fwqrc.com
