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Clinical Electronic Thermometers - Performance, Safety, and Regulatory Requirements

This guidance applies to Class II clinical electronic thermometers regulated under 21 CFR 880.2910 (product code FLL), including both contact and non-contact devices.

  1. Determine if your device falls under the category with or without telethermography/continuous measurement functions
  2. For devices without telethermography/continuous measurement:
    • Ensure compliance with performance and labeling requirements
    • Submit registration and listing within 180 days if not previously done
    • Implement UDI requirements within 180 days if not already compliant
  3. For devices with telethermography/continuous measurement:
    • Submit 510(k) within 180 days if not previously cleared
    • Ensure compliance with all applicable standards
    • Implement required labeling and UDI requirements after FDA clearance
  4. For all devices:
    • Implement quality system requirements
    • Ensure appropriate cybersecurity controls
    • Maintain compliance with applicable standards
    • Provide clear and complete labeling
    • Consider engaging with FDA through Q-Submission Program for specific questions
  5. Document compliance with all applicable standards and maintain technical documentation

Key Considerations

Clinical testing

  • Must conform to ASTM E1112 for electronic thermometers
  • Must conform to ASTM E1965 for infrared thermometers
  • Must conform to ISO 80601-2-56 for clinical thermometers

Non-clinical testing

  • Must demonstrate compliance with electrical safety standards (ANSI/AAMI ES60601-1)
  • Must demonstrate electromagnetic compatibility (ANSI/AAMI/IEC 60601-1-2)
  • Must comply with home healthcare environment requirements if applicable (ANSI/AAMI/IEC 60601-1-11)

Software

  • Must comply with ANSI/AAMI/IEC 62304 for software lifecycle processes
  • Must implement appropriate cybersecurity controls

Cybersecurity

  • Must implement effective cybersecurity controls to ensure device safety and functionality
  • Should follow FDA’s cybersecurity guidance for premarket submissions and postmarket management

Labelling

Must include:

  • Clear description of device performance
  • Method of temperature determination
  • Potential risks
  • Cleaning and reprocessing instructions
  • Probe covers specifications if applicable (ASTM E1104)

Biocompatibility

  • Must comply with ANSI/AAMI/ISO 10993-1 for biological evaluation

Safety

  • Must be manufactured consistent with 21 CFR Part 820 (Quality System Regulation)
  • Must implement appropriate electrical safety measures

Other considerations

  • ASTM E1104: Standard Specification for Clinical Thermometer Probe Covers and Sheaths
  • ASTM E1965: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
  • ASTM E1112: Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
  • ISO 80601-2-56: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers
  • ANSI/AAMI ES60601-1: Medical electrical equipment - General requirements for basic safety and essential performance
  • ANSI/AAMI/IEC 60601-1-2: Medical electrical equipment - Electromagnetic disturbances
  • ANSI/AAMI/IEC 60601-1-11: Medical electrical equipment - Requirements for home healthcare environment
  • ANSI/AAMI/IEC 62304: Medical device software - Software life cycle processes
  • ANSI/AAMI/ISO 10993-1: Biological evaluation of medical devices

Original guidance

  • Clinical Electronic Thermometers - Performance, Safety, and Regulatory Requirements
  • HTML / PDF
  • Issue date: 2023-11-03
  • Last changed date: 2023-11-02
  • Status: FINAL
  • Official FDA topics: Medical Devices, Device & Drug Safety, Premarket, Postmarket
  • ReguVirta summary file ID: f80a2faa1c55a12fa7b92b5b63537a45
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