Compliance with the 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
- 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.