Compliance with FDA
In general, manufacturers of telethermographic systems intended for adjunctive diagnostic screening are required to submit a premarket notification pursuant to section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and 21 CFR 807.81 to FDA and receive FDA clearance prior to marketing these devices in the United States, as well as comply with postmarketing requirements.
To help ensure the availability of products that might offer benefit to health care providers and the general public during the public health emergency, FDA does not intend to object to the distribution and use of telethermographic systems intended for initial body temperature assessment for triage use as described in the Scope (Section III) without compliance with the following regulatory requirements where such devices do not create an undue risk in light of the public health emergency: submission of a premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR 807.81, Reports of Corrections and Removals requirements in 21 CFR Part 806, Registration and Listing requirements in 21 CFR Part 807, the Quality System Regulation in 21 CFR Part 820, and Unique Device Identification (UDI) requirements in 21 CFR Part 830 and 21 CFR 801.20.
An example of such a modification includes a change to the indications for use from the
“measurement of the self-emanating infrared radiation that reveals the relative temperature variations of the surface of the body” to providing an “initial body temperature measurement for triage use.”
FDA believes devices included in this enforcement policy will not create such an undue risk where:
• The performance and labeling elements in Section IV.D are met, and
• An elevated body temperature measurement is confirmed in the context of use with secondary evaluation methods (e.g., non-contact infrared thermometer (NCIT) or clinical grade contact thermometer).
FDA believes such telethermographic devices will not create such an undue risk when the following circumstances related to the performance of the device and the transparency and clarity of information in the product labeling are present.
Alternate E Source is following FDA recommendation that the SmartXcan device:
1) Is tested and labeled consistent with the following standard: IEC 80601-2-59:2017: Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening; OR
2) Is tested using alternative performance specifications that provide similar results to IEC 80601-2-59:2017. This could include:
a) The laboratory temperature accuracy of a screening telethermographic system, including the measurement uncertainty, is less than or equal to ±0.5°C (±0.9°F) over the temperature range of at least 34-39°C (93.2-102.2°F);
b) The system includes an accurate blackbody temperature reference source;10
c) Both stability and drift are less than 0.2°C (0.36°F) within a timeframe specified by the manufacturer; and
d) The device risk assessment addresses all potential safety issues, including:
i) Electrical safety;
ii) Electromagnetic compatibility;
iii) Mechanical safety;
iv) Excessive temperatures and other hazards;
v) Accuracy of controls, instruments, and information display;
vi) Considerations for software associated with Programmable Electrical Medical Systems including network connections;11 and
1) The labeling includes a prominent notice that the measurement should not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease;
2) The labeling includes a clear statement that:
a) Elevated body temperature in the context of use should be confirmed with secondary evaluation methods (e.g., an NCIT or clinical grade contact thermometer);
Noted: This is usually a blackbody (idealized physical body that absorbs all incident electromagnetic radiation) with known temperature and emissivity that can be used for thermal drift compensation.
11 For more information on this recommendation, see Clause 201.14 of IEC 80601-2-59: 2017.
12 This labeling recommendation is consistent with IEC 80601-2-59: 2017.