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.
Recommended Actions
- Prepare comprehensive device description including all specifications and components
- Conduct necessary performance testing for accuracy and precision
- Document biocompatibility for all patient-contacting materials
- Develop complete labeling package with all required elements
- Prepare side-by-side comparison with predicate devices
- Validate software if applicable
- Document sterilization processes if applicable
- Prepare SMDA safety and effectiveness information
- Submit sample device if possible
- Ensure compliance with referenced standards
- 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
- Complete device description including components and materials
- Comparison to legally marketed predicate devices
- Software documentation if applicable
- SMDA safety and effectiveness information
Relevant Guidances
- Clinical Electronic Thermometers - Performance, Safety, and Regulatory Requirements
- Content of Premarket Submissions for Device Software Functions
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- 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.