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This is a draft guidance. Not for implementation.
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
Original guidance
- Basic Safety and Essential Performance Standards in the Accreditation Scheme for Conformity Assessment (ASCA) Program
- HTML / PDF
- Issue date: 2024-09-23
- Last changed date: 2024-10-18
- Status: DRAFT
- Official FDA topics: Medical Devices, Premarket, Biologics
- ReguVirta summary file ID: 8974410844a0e3a1f012c68da3f0ac34
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