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.
What You Need to Know? 👇
What is the FDA’s current enforcement policy for clinical electronic thermometers?
FDA provides relaxed enforcement for certain clinical electronic thermometers, allowing distribution without 510(k) clearance if they don’t create undue risk and meet specific performance standards. The policy varies based on whether devices have telethermography/continuous monitoring functions.
Do clinical electronic thermometers without telethermography functions need 510(k) clearance?
No, FDA doesn’t intend to object to distribution of these devices without 510(k) clearance if they don’t create undue risk. FDA is also proposing to exempt these devices from premarket notification requirements entirely.
What is the transition period for thermometers with telethermography or continuous monitoring?
Devices with these advanced functions have a 180-day transition period from November 3, 2023, to submit required 510(k) notifications if they want to continue distribution after this period.
What performance standards must clinical electronic thermometers meet under this policy?
Devices must comply with 21 CFR Part 820, have authorization in recognized jurisdictions (CE Mark, Health Canada, etc.), or conform to specific ASTM/ISO standards for thermometers, electrical safety, software, and biocompatibility.
Are there cybersecurity requirements for thermometers with remote monitoring capabilities?
Yes, manufacturers must meet cybersecurity requirements and should refer to FDA’s cybersecurity guidance for medical devices, especially for modifications that increase remote monitoring capability which may impact cybersecurity risks.
What labeling requirements apply to clinical electronic thermometers under this policy?
Device labeling must include clear descriptions of performance data, temperature measurement methods, potential risks, and cleaning/reprocessing instructions. Additional labeling requirements may apply during transition periods for certain device types.
What You Need to Do 👇
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