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There are many products marketed in the United States as telethermographic systems that detect infrared radiation and convert such measurements into a temperature measurement. Telethermographic systems that meet the definition of a device under section 201(h) of the FD&C Act (21 U.S.C. 321(h)) are regulated by FDA. Generally, telethermographic systems fall within the definition of a device when they are intended for a medical purpose, including for use by health care professionals or others for body temperature assessment.8 Telethermographic systems that are not intended for a medical purpose are not medical devices as described in further detail below. The enforcement policy in this guidance applies to telethermographic systems that are intended for adjunctive diagnostic screening during the COVID-19 pandemic. These products may be devices that are regulated under 21 CFR 884.2980(a), product code LHQ, 9 and have been modified as explained below, or products that normally are not considered devices under the FD&C Act, but that may be used for a medical purpose during the COVID-19 pandemic to address availability concerns of such products.

Telethermographic Systems Not Intended for a Medical Purpose Telethermographic systems are devices when they meet the definition of a device set forth in section 201(h) of the FD&C Act (21 U.S.C. 321(h)). Under section 201(h) of the FD&C Act (21 U.S.C. 321(h)), these products are devices when they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease.
Telethermographic systems may be marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications. Because they are not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, when marketed for these non-medical applications, FDA device marketing authorization is not required, and all the other medical device requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of these products. Telethermographic systems are devices when they are intended for a medical purpose, such as measurement of the self-emanating infrared radiation that reveals the relative temperature variations of the surface of the body. When evaluating whether these products are intended for a medical purpose, among other considerations, FDA will consider whether: 1) They are labeled or otherwise intended for use by a health care professional; 2) They are labeled or otherwise for use in a health care facility or environment; and 3) They are labeled for an intended use that meets the definition of a device, e.g., body temperature measurement for diagnostic purposes, including such use in non-medical environments (e.g., airports). The enforcement policy outlined below is intended to apply to all telethermographic systems that are intended for medical purposes for the duration of the public health emergency related to COVID-19. As such, FDA recommends that manufacturers of telethermographic systems that were not previously intended for medical purposes, but that are now intended for medical purposes, review the enforcement policy in Section IV.C. C. Telethermographic Systems Intended for Adjunctive Diagnostic Screening 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: Contains Nonbinding Recommendations 5 • 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). D. Performance and Labeling 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. FDA recommends that the 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 vii)Usability. In addition, FDA recommends that the devices described above use labeling that helps users better understand the device, such as: 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);1  
 

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