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Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for Medical Device Testing Laboratories

This guidance describes the implementation of the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, which establishes a framework for accreditation bodies to accredit testing laboratories that assess medical device conformity with FDA-recognized consensus standards. The guidance outlines the roles, responsibilities, processes and policies for accreditation bodies, testing laboratories, device manufacturers, and FDA staff participating in the program.

  1. Review eligibility requirements and determine if organization qualifies for participation as accreditation body or testing laboratory
  2. Submit application to FDA with required documentation demonstrating competence and compliance with program requirements
  3. Complete required FDA training before conducting any ASCA activities
  4. Implement processes to:
    • Conduct testing/accreditation according to ISO standards and ASCA specifications
    • Maintain appropriate documentation and records
    • Report changes and issues to FDA within required timeframes
    • Submit regular updates and annual reports
    • Handle complaints and corrective actions
  5. Establish communication channels with FDA for ongoing program participation
  6. For device manufacturers:
    • Verify testing laboratory’s ASCA accreditation status and scope
    • Work with laboratory to develop appropriate test plans
    • Include required ASCA documentation in premarket submissions
  7. Monitor FDA communications and guidance updates for any program changes
  8. Maintain compliance with all program requirements to avoid suspension or withdrawal

Key Considerations

Non-clinical testing

  • Testing laboratories must conduct testing in accordance with ISO/IEC 17025 and ASCA program specifications
  • Testing must be performed within the laboratory’s scope of ASCA Accreditation
  • Testing laboratories must provide ASCA summary test reports and all information listed in relevant ASCA program specifications

Labelling

  • Testing laboratories must clearly label testing conducted during periods of suspension
  • Device manufacturers must indicate in DOCs whether testing was impacted by suspension
  • Testing conducted outside scope of ASCA Accreditation should not be labeled as part of ASCA Pilot

Biocompatibility

  • Biocompatibility testing under ASCA Pilot must be conducted in accordance with 21 CFR 58 Good Laboratory Practices regulations
  • Testing laboratories must provide copies of SOPs and relevant test documents for biocompatibility testing

Other considerations

  • ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories
  • ISO/IEC 17000:2004: Conformity assessment – Vocabulary and general principles
  • ISO/IEC 17011:2017: Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies

Original guidance

  • Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for Medical Device Testing Laboratories
  • HTML / PDF
  • Issue date: 2020-09-25
  • Last changed date: 2024-08-09
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Biologics
  • ReguVirta summary file ID: e4cae75c70dacc2c7ca05f05892f5712
This post is licensed under CC BY 4.0 by the author.