The COVID-19 pandemic has dictated the need for measures to be taken to provide a means to conveniently screen persons for elevated skin temperatures which may be predictor of fever. ICI Thermal Imaging Camera Systems are one of the solutions capable of this mission.

The US Food and Drug Administration (FDA) issued an Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency in April of 2020. You can find this policy on the FDA’s website at:

https://www.fda.gov/media/137079/download

The FDA guidance states that FDA does not intend to object to the distribution and use of telethermographic systems intended for initial body temperature assessment for triage during the public health emergency where such devices do not create undue risk to the public. To support this position the FDA stipulated specific device performance criteria and labeling be provided to the users of the telethermographic systems addressing the proper use and limitations of thermographic screening devices. This supplement is intended to be used in addition to the user manual that accompanied the system.