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Clinical Electronic Thermometers - Review Requirements and Testing Specifications

This guidance establishes the 510(k) review requirements for clinical electronic thermometers that measure oral, axillary, rectal, or tympanic temperature utilizing various methods. The guidance excludes clinical mercury thermometers and clinical color change thermometers.

  1. Prepare comprehensive device description including all specifications and components
  2. Conduct necessary performance testing for accuracy and precision
  3. Document biocompatibility for all patient-contacting materials
  4. Develop complete labeling package with all required elements
  5. Prepare side-by-side comparison with predicate devices
  6. Validate software if applicable
  7. Document sterilization processes if applicable
  8. Prepare SMDA safety and effectiveness information
  9. Submit sample device if possible
  10. Ensure compliance with referenced standards
  11. Maintain complete test documentation for potential FDA requests

Key Considerations

Non-clinical testing

  • Accuracy characterization over entire temperature range specified
  • Precision and repeatability testing over temperature range
  • Effects of air currents on accuracy, precision and repeatability
  • Additional testing may be needed for unique designs

Software

  • Must indicate level of concern for software-controlled thermometers
  • Must provide appropriate software information according to reviewer guidance

Labelling

  • Must include types of temperature measurements possible
  • Device specifications (temperature range, accuracy, precision)
  • Ambient temperature range for device use
  • Directions for use for all functions
  • Instructions for probe covers use and cleaning/disinfection
  • Maintenance and recalibration instructions
  • Instructions for interpreting output vs core body temperature
  • Time required for steady state reading

Biocompatibility

  • Must certify biocompatibility for all body tissue/fluid contacting materials
  • Documentation required according to Tripartite Biocompatibility Guidance
  • Additional testing may be needed for non-standard colors

Safety

  • Must meet power/energy safety requirements
  • If sterilized, must provide sterilization validation method and sterility assurance level

Other considerations

  • ASTM E1112-86: Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
  • ASTM E1104-86: Standard Specification for Clinical Thermometers Probe Covers and Sheaths
  • UL 544: Standards for safety, medical and dental equipment
  • IEC 601-1/ANSI ES1-1985: Safe Current Limits for Electromedical Apparatus

Original guidance

  • Clinical Electronic Thermometers - Review Requirements and Testing Specifications
  • HTML
  • Issue date: 1993-02-28
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: 0bd57b9e3acfbac17ea5099085aa4d4a
This post is licensed under CC BY 4.0 by the author.