Biocompatibility Testing Standards and Accreditation Requirements in the ASCA Program (DRAFT)
This guidance provides information on how biocompatibility testing standards are incorporated into the Accreditation Scheme for Conformity Assessment (ASCA) Program. It details specifications for accreditation bodies assessing testing laboratories and requirements for testing laboratories conducting biocompatibility testing under the ASCA Program. The guidance covers specific test methods for biocompatibility evaluation including cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility testing.
This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What is the ASCA Program and how does it apply to biocompatibility testing?
The ASCA (Accreditation Scheme for Conformity Assessment) Program is FDA’s initiative that allows accredited testing laboratories to conduct biocompatibility testing for medical devices using FDA-recognized consensus standards. It enhances confidence in testing results through standardized procedures and accreditation requirements.
Which biocompatibility test methods are included in the ASCA Program?
The ASCA Program includes specific test methods from ISO 10993 standards, such as MEM elution cytotoxicity, hemolysis testing, sensitization studies, irritation testing, systemic toxicity, and complement activation. Not all test methods within these standards are eligible for ASCA.
What are the key requirements for testing laboratories seeking ASCA accreditation?
Testing laboratories must demonstrate competence through ISO/IEC 17025 compliance, maintain qualified technical personnel with specific education and experience requirements, follow 21 CFR 58 GLP regulations, and establish comprehensive training programs including periodic proficiency checks for subjective analyses.
What types of medical devices are excluded from ASCA biocompatibility testing?
Devices requiring customized sample preparation, absorbable devices, in situ polymerizing devices, liquid devices, creams, gels, hydrogel devices, and devices containing nanomaterials are excluded from the ASCA Program due to their specialized testing requirements.
What documentation is required for premarket submissions using ASCA testing results?
Submissions must include an ASCA Declaration of Conformity (DOC), ASCA Summary Test Reports, and potentially complete test reports depending on specific circumstances such as deviations from standard procedures or unexpected findings during testing.
When might FDA request additional information beyond ASCA Summary Test Reports?
FDA may request complete test reports when there are deviations from standard procedures, unexpected test results, extract manipulation, adverse findings in animal studies, or when control values fall outside expected ranges, as these circumstances may indicate potential safety concerns.
What You Need to Do 👇
Recommended Actions
- Review scope of biocompatibility testing needed based on device type and contact duration
- Verify device eligibility for ASCA Program testing (not excluded categories)
- Select ASCA-accredited testing laboratory with appropriate scope of accreditation
- Ensure test article preparation follows requirements for extraction conditions and ratios
- Confirm testing laboratory follows required procedures and acceptance criteria for each test method
- Review test reports and ASCA Declarations of Conformity for completeness
- Include complete test reports if any results fall outside acceptance criteria
- Maintain documentation of testing laboratory accreditation status at time of testing
- Implement quality system procedures to ensure ongoing compliance with ASCA Program requirements
- Train relevant personnel on ASCA Program requirements and procedures
- Establish procedures for sample preparation and handling according to guidance specifications
- Maintain records demonstrating compliance with animal welfare requirements for in vivo testing
Key Considerations
Non-clinical testing
- Testing must be conducted according to 21 CFR 58 Good Laboratory Practices (GLP) regulations
- Testing laboratories must be previously inspected for GLP compliance by FDA
- Specific test methods and acceptance criteria are defined for each biocompatibility test
- Testing laboratories must maintain competent technical personnel with relevant experience and education
- Detailed procedures and documentation required for sample preparation, testing, and data analysis
Biocompatibility
- Specific test methods included: cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility
- Detailed specifications for each test method regarding procedures, controls, acceptance criteria
- Sample preparation and extraction requirements defined
- Exclusions: customized sample preparation/testing, absorbable devices, in situ polymerizing devices, liquid devices, creams, gels, hydrogel devices, devices with nanomaterials
Safety
- Animal welfare requirements must be followed for in vivo testing
- Personnel must be trained on proper animal handling and care procedures
- Procedures required for monitoring animal health and adverse events
Other considerations
- Testing laboratories must maintain accreditation through ASCA-recognized accreditation bodies
- Quality management system requirements per ISO/IEC 17025
- Documentation and record-keeping requirements
- Personnel training and competency requirements
- Equipment calibration and maintenance requirements
Relevant Guidances 🔗
- The Accreditation Scheme for Conformity Assessment (ASCA) Program for Medical Device Testing Laboratories (Draft)
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
Related references and norms 📂
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-2: Biological evaluation of medical devices - Part 2: Animal welfare requirements
- ISO 10993-3: Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- 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 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
- ISO 10993-23: Biological evaluation of medical devices - Part 23: Tests for irritation
- ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories
- ASTM F756: Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F720: Standard Practice for Testing Guinea Pigs for Contact Allergens