Basic Safety and Essential Performance Standards for Medical Electrical Equipment Under the ASCA Pilot Program
This guidance outlines how basic safety and essential performance standards are incorporated into the ASCA Pilot Program. It provides specifications for accreditation of testing laboratories and requirements for premarket submissions containing test results from ASCA-accredited laboratories for medical electrical equipment, medical electrical systems, and laboratory medical equipment.
What You Need to Know? 👇
What is the ASCA program and how does it impact medical device testing?
The Accreditation Scheme for Conformity Assessment (ASCA) is a permanent FDA program that allows accredited testing laboratories to conduct safety testing for medical devices. It streamlines premarket submissions by providing enhanced confidence in test results from qualified laboratories.
Which medical device standards are included in the ASCA program for electrical safety?
The ASCA program covers IEC 60601/80601 series standards for medical electrical equipment and IEC 61010-1 for laboratory equipment. This includes general requirements, collateral standards, and nearly 100 particular standards for specific device types like infusion pumps and incubators.
What additional documentation is required for ASCA testing submissions?
ASCA submissions require a Declaration of Conformity with specific elements including testing dates, laboratory accreditation status, and an ASCA Summary Test Report. The submission must also address any test modifications, observations, and concerns identified during testing.
How does ASCA accreditation differ from standard ISO/IEC 17025 laboratory accreditation?
ASCA-accredited laboratories must meet ISO/IEC 17025 requirements plus additional program specifications. These include enhanced personnel training requirements, specific equipment procedures, detailed test reporting obligations, and requirements for handling risk management file inspections.
What happens if test methods need to be modified during ASCA testing?
Modified test methods are permitted under specific conditions outlined in IEC 60601-1 and ISO/IEC 17025. The testing laboratory must document the modifications, provide detailed test procedures and acceptance criteria, and include this information in the ASCA Summary Test Report.
Can manufacturer internal laboratories participate in the ASCA program?
Yes, but manufacturer internal laboratories must have specific policies ensuring impartiality when testing devices from their parent organization. They must demonstrate separation of testing activities from other services and protect against business interest conflicts in their testing decisions.
What You Need to Do 👇
Recommended Actions
- Ensure testing laboratory has proper accreditation and scope for ASCA program
- Implement procedures for:
- Personnel training and competency assessment
- Equipment calibration and maintenance
- Test method validation and documentation
- Risk management file review
- Test report generation
- Prepare required documentation for premarket submissions:
- Cover letter indicating ASCA program participation
- Declaration of Conformity with additional ASCA-specific elements
- ASCA Summary Test Report
- Supplemental documentation for modified test methods
- Maintain records of:
- Personnel qualifications and training
- Equipment calibration and maintenance
- Test procedures and results
- Risk management file reviews
- Communications with manufacturers
- Establish quality system procedures to ensure:
- Impartiality of testing activities
- Proper handling of test items
- Valid test results
- Appropriate reporting
- Management of nonconforming work
Key Considerations
Non-clinical testing
- Testing laboratories must inspect manufacturer’s risk management file to assess compliance with IEC 60601/80601 or IEC 61010 standards
- Testing laboratories must not make judgments about risk management process adequacy or risk acceptability
- Testing must be conducted considering FDA guidance recommendations
- Modified test methods are allowed within ASCA Pilot if details and results are provided
Human Factors
- Testing laboratories must ensure relevant contextual information from intended use and manufacturer’s essential performance specifications are reflected in test procedures
Labelling
- Test reports must include detailed device description including accessories, options, software versions and configurations tested
- Labeling requirements of standards must be documented in premarket submissions
Safety
- Testing laboratories must ensure all equipment used is available and in proper working order
- Procedures must specify calibration intervals and criteria
- Procedures must address defective/out-of-tolerance equipment effects
- Test procedures must include warnings/cautions about potential hazards
Other considerations
- Testing laboratories must maintain impartiality through separation of consulting/design services from testing
- Technical personnel must be qualified and competent to establish and carry out test methods
- Ongoing training of technical personnel is required
- Test reports must include detailed information about test conditions, data, and results
- ASCA Summary Test Report must be provided to clients
Relevant Guidances 🔗
- Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for Medical Device Testing Laboratories
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
Related references and norms 📂
- ISO/IEC 17011: Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies
- ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories
- IEC 60601/80601 series: Medical electrical equipment standards
- IEC 61010 series: Safety requirements for electrical equipment for measurement, control and laboratory use