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.
Recommended Actions
- Review eligibility requirements and determine if organization qualifies for participation as accreditation body or testing laboratory
- Submit application to FDA with required documentation demonstrating competence and compliance with program requirements
- Complete required FDA training before conducting any ASCA activities
- 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
- Establish communication channels with FDA for ongoing program participation
- 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
- Monitor FDA communications and guidance updates for any program changes
- 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
- Accreditation bodies must maintain ILAC MRA signatory status
- Testing laboratories must be accredited by ASCA-recognized accreditation bodies
- Participants must complete required FDA training before conducting ASCA activities
- Regular communication with FDA required, including notifications of changes within 5 days
- Annual reports and updates must be provided to FDA
- FDA maintains discretion to suspend or withdraw participation at any time
Relevant Guidances
- Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Basic Safety and Essential Performance Standards for Medical Electrical Equipment Under the ASCA Pilot Program
- The Accreditation Scheme for Conformity Assessment (ASCA) Program for Medical Device Testing Laboratories (Draft)
- Biocompatibility Testing Standards and Accreditation Requirements in the ASCA Program (Draft)
- Basic Safety and Essential Performance Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Program (Draft)
Related references and norms
- 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
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