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Premarket Notification Requirements for Cardiac Monitors, Heart Rate Meters, and Alarms

This guidance applies to cardiac monitors regulated under 21 CFR §870.2300 (Class II devices) covered by ANSI/AAMI EC13-1992 standard for Cardiac Monitors, Heart Rate Meters, and Alarms. It excludes fetal heart rate monitors, pulse plethysomographic devices, invasive monitors, ambulatory ECG devices, and Class III devices with real-time arrhythmia detection capabilities.

  1. Prepare comprehensive device description including all required specifications and intended use
  2. Conduct performance testing either through comparison or standards conformance
  3. Perform required safety testing (electrical, EMC, environmental)
  4. Prepare software documentation based on level of concern
  5. Ensure all patient-contacting materials are properly documented
  6. Develop compliant labeling including all required elements
  7. Prepare regulatory documentation (510(k) Statement, Truthful and Accuracy Statement)
  8. For transport use devices, conduct additional EMC and environmental testing
  9. Document conformance to applicable standards or justify any deviations
  10. Prepare test reports following the suggested format (protocol, data/results, analysis)

Key Considerations

Non-clinical testing

  • Performance testing through either:
    • Comparison testing with predicate device
    • Conformance to EC13 standard
    • Conformance to equivalent standards
  • Environmental testing for expected use conditions
  • Electromagnetic compatibility testing (emissions and immunity)
  • Electrical safety testing

Software

  • Documentation requirements based on level of concern (minor to moderate)
  • Refer to “Guidance for Content of Premarket Submissions for Software Contained in Medical Devices”

Labelling

  • Must comply with 21 CFR 807.87(e)
  • Include EC13 standard labeling requirements if applicable

Biocompatibility

  • Material descriptions required for all patient contacting materials

Safety

  • Electrical safety testing per appropriate standards (ANSI/AAMI ES-1, IEC 601-1)
  • EMC testing for hospital environment (minimum 3 V/m immunity)
  • Enhanced EMC testing (20 V/m) for transport environment use

Other considerations

  • ANSI/AAMI EC13-1992: Cardiac monitors, heart rate meters, and alarms
  • ANSI/AAMI EC38-1994: Ambulatory electrocardiographs
  • ANSI/AAMI ES1-1993: Safe current limits for electromedical apparatus
  • IEC 60601-1-2: Medical Electrical Equipment - EMC Requirements and Tests
  • IEC 68-2-6: Environmental Testing - Vibration
  • IEC 529: Classification of Degrees of Protection Provided by Enclosures

Original guidance

  • Premarket Notification Requirements for Cardiac Monitors, Heart Rate Meters, and Alarms
  • HTML / PDF
  • Issue date: 1998-11-04
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Cardiovascular, Premarket
  • ReguVirta summary file ID: d651828ffd540e7eedff10924badc286
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