Basic Safety and Essential Performance Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Program (DRAFT)
This guidance outlines how basic safety and essential performance standards are incorporated into the Accreditation Scheme for Conformity Assessment (ASCA) Program. It covers: - ASCA Program specifications for FDA-recognized consensus standards and test methods - Assessment and accreditation of Testing Laboratories by ASCA-recognized Accreditation Bodies - Recommended premarket submission contents when testing is conducted by ASCA-accredited laboratories
This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What is the ASCA Program and how does it apply to medical electrical equipment testing?
The ASCA Program (Accreditation Scheme for Conformity Assessment) is FDA’s initiative to enhance confidence in testing results for medical devices. It applies to basic safety and essential performance testing of medical electrical equipment using FDA-recognized consensus standards like IEC 60601/80601 and IEC 61010 series.
What are the key requirements for testing laboratories to participate in ASCA for electrical safety testing?
Testing laboratories must be accredited to ISO/IEC 17025 and meet specific ASCA Program specifications. Key requirements include maintaining qualified personnel, proper equipment calibration procedures, comprehensive test procedures, and the ability to provide ASCA Summary Test Reports with detailed documentation of testing activities and results.
How should essential performance be defined and documented in ASCA testing?
Essential performance must be specified by the device manufacturer and clearly documented in test plans. Testing laboratories should assist manufacturers in understanding this concept. If uncertain, FDA recommends submitting a Q-submission for formal feedback. The AAMI consensus report CR500:2019 provides helpful clarifications on essential performance.
What documentation is required when submitting ASCA testing results to FDA?
Submissions must include an ASCA Declaration of Conformity (ASCA DOC) and an ASCA Summary Test Report. The ASCA DOC expands on standard DOC requirements, including testing dates, locations, accreditation status, and limitations. The Summary Test Report provides comprehensive testing details without requiring full test reports.
Can ASCA-accredited testing laboratories subcontract testing to other facilities?
Yes, ASCA-accredited testing laboratories may subcontract testing as allowed by ISO/IEC 17025, provided the subcontracted testing is within the laboratory’s scope of ASCA Accreditation. The ASCA-accredited laboratory remains responsible for all data, methodology, and results presented in reports to device manufacturers.
How should testing laboratories handle concerns or observations during ASCA testing?
Testing laboratories must communicate concerns to device manufacturers and work to resolve them before issuing reports. Unresolved concerns must be detailed in the ASCA Summary Test Report. Observations and degradations during testing must be documented, including unexpected behaviors, even if deemed acceptable per pass/fail criteria.
What You Need to Do 👇
Recommended Actions
- Review scope of ASCA accreditation and ensure all relevant standards are covered
- Develop comprehensive test plans in collaboration with device manufacturers including:
- Essential performance characteristics
- Device-specific pass/fail criteria
- Use environment specifications
- Document all testing procedures and results according to ASCA requirements:
- Complete ASCA Summary Test Reports
- Prepare ASCA Declaration of Conformity
- Include any modifications to test methods or acceptance criteria
- Address any concerns or observations:
- Document and communicate concerns to manufacturers
- Include resolutions in submission documentation
- Provide rationale for any unresolved issues
- Maintain proper documentation for:
- Personnel qualifications and training
- Equipment calibration and maintenance
- Test procedures and results
- Risk management file reviews
- Ensure separation of testing from other services to maintain impartiality
- Review and comply with relevant FDA guidance documents referenced in the standard
Key Considerations
Non-clinical testing
- Testing laboratories must maintain technical personnel qualified to establish and perform appropriate test methods
- Test procedures must be documented and reviewed prior to use
- Test reports must include detailed description of the medical device tested, test conditions, and results
- Modified test methods must be justified and documented
Labelling
- Labeling requirements of the standard must be met and referenced in documentation
- Information on how labeling requirements are met must be included in Declaration of Conformity
Safety
- Testing laboratories must evaluate device manufacturer’s risk management file for compliance
- Essential performance characteristics must be specified and monitored during testing
- Pass/fail criteria specific to the device must be clear and verifiable
- All hazards must be addressed either through standards or risk management process
Other considerations
- Testing laboratories must maintain impartiality through separation of testing from other services
- Facilities and equipment must be appropriate and properly maintained
- Records of all testing activities must be maintained
- Subcontracting is allowed if within scope of ASCA Accreditation
Relevant Guidances 🔗
- Basic Safety and Essential Performance Standards for Medical Electrical Equipment Under the ASCA Pilot Program
- Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for Medical Device Testing Laboratories
- The Accreditation Scheme for Conformity Assessment (ASCA) Program for Medical Device Testing Laboratories (Draft)
Related references and norms 📂
- ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories
- ISO/IEC 17011: Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies
- IEC 60601/80601: Medical electrical equipment series
- IEC 61010: Safety requirements for electrical equipment for measurement, control, and laboratory use