No, it is not FDA approved nor certified but is FDA compliant. The Temperature Screening Assistant does follow the FDA guidelines for thermal imaging systems used during Covid 19 Public Health Emergency. This exemption and the accompanying recommendations have been provided for these devices for use during the pandemic. Per the FDA recommendations, it utilizes a temperature reference source. We recommend that an elevated body temperature in the context of use should be confirmed with secondary evaluation methods such as a person manually taking the temperatures with an FDA approved thermometer.