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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
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Questions?
If you have questions about the ASCA program or this update, contact the Division of Industry and Consumer Education.
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