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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.

  1. Ensure testing laboratory has proper accreditation and scope for ASCA program
  2. Implement procedures for:
    • Personnel training and competency assessment
    • Equipment calibration and maintenance
    • Test method validation and documentation
    • Risk management file review
    • Test report generation
  3. 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
  4. Maintain records of:
    • Personnel qualifications and training
    • Equipment calibration and maintenance
    • Test procedures and results
    • Risk management file reviews
    • Communications with manufacturers
  5. 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

  • 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

Original guidance

  • Basic Safety and Essential Performance Standards for Medical Electrical Equipment Under the 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 summary file ID: a2e88b55a881269f601db746fb2871d1
This post is licensed under CC BY 4.0 by the author.