When you received your NC° Thermometer Gen3, you may have noticed a sticker on the packaging stating: “This thermometer is being imported under FDA Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 Public Health Emergency. This device meets performance requirements but is not yet FDA-cleared.”
The NC° Thermometer Gen3 has been rigorously tested and we can confirm that it meets all the requirements for safe and effective use in the US under this FDA policy (more details on the policy below).
We are also actively pursuing FDA clearance through the 510(k) process and will update this article once the 510(k) clearance has been obtained.
Requirements for distribution and use of clinical electronic thermometers that are not currently 510(k) cleared under FDA Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID19) Public Health Emergency:
- The thermometer is manufactured consistent with 21 CFR Part 820 and ISO 13485:2016.
- The thermometer meets the following standards:
- ASTM E1112-00 (Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
- ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ANSI/AAMI ES60601-1:2005/(R2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ANSI/AAMI/IEC 60601-1-2: 2014: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
- ANSI/AAMI/IEC 60601-1-11:2015: Medical Electrical Equipment – Part 1-11:
- General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment
- ANSI/AAMI/IEC 62304: 2006/A1:2016 Medical device software - Software life cycle processes
- ANSI/AAMI/ISO 10993-10 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- The device labeling includes a clear description of the available data on the device’s indications or functions (take a look at NC° Thermometer Gen3 IFU for this information)
- The device labeling includes a clear identification that the device is not FDA approved or cleared (which is why there is a sticker stating this on the packaging).