ANAB has been recognized as an accreditation body (AB) for the U.S. Food & Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot program and has begun to assess laboratories for compliance to its requirements.
ANAB offers accreditation activities for laboratories performing both the Basic Safety and Essential Performance standards and Biocompatibility standards included in the Pilot. Laboratories accredited by ANAB to the ASCA Pilot standards may then apply directly to the FDA for recognition to the program.
About the FDA Accreditation Scheme for Conformity Assessment (ASCA) Program
Launched on September 25, 2020, the U.S. Food & Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot program grants ASCA recognition to qualified accreditation bodies to accredit testing laboratories to perform premarket testing for medical device companies.
Participants in the program include accreditation bodies (like ANAB), testing laboratories, device manufacturers, and FDA staff. The ASCA Pilot is based off three guiding documents:
- Program guidance
- Basic safety and essential performance standards-specific guidance
- Biocompatibility standards-specific guidance
Created by the FDA using input from experts across the medical device manufacturing and standards conformity assessment communities, the ASCA Pilot potentially decreases the burden of individual premarket submissions and incorporates existing international conformity assessment standards and practices. In result, the program should decrease the need for the FDA to request additional information regarding testing methodologies when a premarket submission includes declarations of conformity to an FDA-recognized consensus standard eligible for inclusion in the ASCA Pilot.
Considering these intentions, the Pilot program should help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices.
Learn More about ANAB Accreditation to FDA ASCA
Laboratories interested in learning about the ASCA program requirements and accreditation process should contact their Accreditation Managers with ANAB, who are happy to assist you in learning more about the program requirements, completing an application to outline your laboratory’s participation, and scheduling the assessment activity.
Laboratories participating in the ASCA Pilot program are required to be accredited to ISO/IEC 17025:2017. The FDA ASCA Pilot program requirements are supplemental requirements in addition to ISO/IEC 17025:2017 accreditation. For laboratories participating in Biocompatibility testing, ANAB will also assess the laboratory for compliance to 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies (GLP).