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.
Recommended Actions
- Determine if your device falls under the category with or without telethermography/continuous measurement functions
- 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
- 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
- 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
- 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
- Devices with telethermography or continuous measurement functions require additional regulatory considerations
- 180-day transition period for compliance with certain requirements
- Marketing authorization required from FDA or other recognized jurisdictions (EU, Australia, Canada, Japan)
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Clinical Electronic Thermometers - Review Requirements and Testing Specifications
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
Related references and norms
- 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
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