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Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. It covers: - List of FDA-recognized consensus standards and test methods for biocompatibility testing - Program specifications for accreditation of testing laboratories - Recommended premarket submission contents when testing is conducted by ASCA-accredited labs The guidance excludes devices requiring customized sample preparation/testing, absorbable and in situ polymerizing devices, liquid devices, creams, gels, hydrogel devices, and devices containing nanomaterials.

  1. Review scope of testing needed based on device characteristics and intended use
  2. Select ASCA-accredited testing laboratory with appropriate scope of accreditation
  3. Ensure test article preparation follows requirements and document any deviations
  4. Verify testing follows specified methods and acceptance criteria
  5. Document all test results including controls and any observations
  6. Prepare Declaration of Conformity with required elements
  7. Include ASCA Summary Test Reports in premarket submission
  8. Submit complete test reports if required based on results/observations
  9. Maintain records of all testing and documentation
  10. Implement process for handling any deviations or nonconforming results

Key Considerations

Non-clinical testing

  • Testing laboratories must maintain competent technical personnel with specific qualifications and experience for in vivo and in vitro testing
  • Training programs and records must be documented and maintained
  • Procedures for sample preparation and test-specific training must be established
  • Quality control procedures including proficiency checks must be implemented
  • Test procedures must follow FDA-recognized standards and GLP regulations

Biocompatibility

  • Testing must follow ISO 10993 standards and FDA guidance
  • Specific test methods are defined for cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility
  • Controls and acceptance criteria are specified for each test method
  • Changes to test procedures require FDA review
  • Complete test reports required for certain results/observations

Safety

  • Testing laboratories must follow GLP regulations
  • Procedures needed for equipment calibration and maintenance
  • Processes required for handling test/control samples
  • Documentation of any deviations or adverse findings

Other considerations

  • ASTM F756: Standard Practice for Assessment of Hemolytic Properties of Materials
  • ASTM F720: Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
  • ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
  • ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
  • ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
  • ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
  • USP <151>: Pyrogen Test

Original guidance

  • Biological Evaluation of Medical Devices Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
  • HTML / PDF
  • Issue date: 2020-09-25
  • Last changed date: 2023-09-19
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Biologics
  • ReguVirta summary file ID: a394a9990bd474f8bda8ba1d23e1d76d
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