DW E.S.T. (Elevated Skin Temperature) System
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11.4. Compliance
1. Is the solution classified as a medical device?
a. No. In the USA, the camera and Blackbody have been designed to meet the U.S. Food & Drug
Administration’s April 2020 Enforcement Policy for Thermographic Systems. However, it is NOT
classified as a medical device and is not intended to detect or diagnose a disease or any health
conditions. The product is intended to use as a first-line filter to identify people entering a facility who
may have an elevated body temperature. If elevated skin temperature is detected, organizations
should always follow up with additional screening with medical devices such as a thermometer and
medical questionnaire. Organizations should then determine the appropriate action for that
information. Temperature measurements should not be the only or primary tool of diagnosis or
exclusion diagnosis of COVID-19 or any other disease.
