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

What You Need to Know? 👇

What is the ASCA program and how does it impact biocompatibility testing for medical devices?

The ASCA (Accreditation Scheme for Conformity Assessment) program is FDA’s initiative to enhance confidence in testing results from accredited laboratories. For biocompatibility testing, it provides standardized procedures and requirements for testing laboratories, potentially streamlining FDA review processes when testing is conducted by ASCA-accredited facilities.

Which biocompatibility test methods are included in the ASCA pilot program?

The ASCA pilot includes key biocompatibility tests such as cytotoxicity (MEM elution), irritation testing (intracutaneous reactivity, dermal irritation), sensitization testing (guinea pig maximization, closed patch), systemic toxicity, pyrogenicity, hemolysis, and complement activation. These cover the most common biocompatibility assessments required for medical device submissions.

What are the key personnel qualification requirements for ASCA-accredited biocompatibility testing laboratories?

Technicians need 1 year relevant experience or demonstrated proficiency through 25 tests, plus appropriate education (bachelor’s/associate degree or laboratory technician certification). Study directors require bachelor’s degree, 2 years experience, and direction of at least 25 studies. All personnel need documented training and periodic requalification.

When must a complete test report be submitted instead of just an ASCA summary report?

Complete test reports are required when there are deviations from standard procedures, unexpected results (like positive controls failing, adverse findings in animals), non-standard extraction conditions, or when test articles show color changes, turbidity, or degradation during testing.

What types of medical devices are excluded from ASCA biocompatibility testing?

Excluded devices include absorbable and in situ polymerizing devices, liquid devices, creams, gels, hydrogel devices, and devices containing nanomaterials. These require customized sample preparation or testing methodologies not covered under the standardized ASCA approach.

How does the Declaration of Conformity differ for ASCA-tested devices versus standard testing?

ASCA Declarations of Conformity must include additional information such as testing dates, laboratory ASCA accreditation status during testing, confirmation that standards were within the lab’s scope of accreditation, and details about any accreditation suspensions that may have affected testing validity.

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What You Need to Do 👇

Recommended Actions

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

• Testing laboratories must maintain impartiality
• Subcontractors must be ASCA-accredited
• Records and documentation requirements specified
• Procedures for handling complaints and nonconforming work needed

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Relevant Guidances 🔗

• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
• Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for Medical Device Testing Laboratories

Related references and norms 📂

• 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

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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 ID: a394a9990bd474f8bda8ba1d23e1d76d