Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1FDA’s review of your website revealed the following statements that establish that the Therm-App MD and Therm-App MD Pro are intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including: • “Have you seen our case study about using thermal cameras to help prevent the spread of COVID-19?” [Published as a pop-up on your Therm-App MD Pro webpage, https://www.opgal.com/products/therm-app-md-pro] • “HELP MINIMIZE THE SPREAD OF THE CORONA VIRUS OUTBREAK.” [Published in your YouTube video titled, “Therm-App MD by Opgal”, https://www.youtube.com/watch?v=2bmmXY8158I] • “The skies are gradually opening up again, and it's time to put the ThermApp MD PRO up to the test... #airportsecurity #airport #covidsolutions #thermalimaging #thermalcameras #feverscreening” [Published your Twitter webpage, https://twitter.com/OpgalLtd/status/1310828682022453248] • “Elevated body temperature becomes another security concern in this day and age. Opgal's thermal imaging technology has got you covered here as well… #thermalimaging #security #covid19solutions” [Published on your Facebook webpage, https://www.facebook.com/Opgal/videos/721164435451235/?__tn__=-R]
Passage 2The Therm-App MD and Therm-App MD Pro are offered for sale in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, your products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your products are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce these products into interstate commerce for commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Passage 3Your website, https://www.opgal.com, includes statements that indicate that the Therm-App MD and Therm-App MD Pro are intended to scan multiple individuals simultaneously, including: • For the Therm-App MD Pro, “Multiple Hotspot Detection & Tracking” [Published in your Therm-App MD Pro Brochure, https://www.opgal.com/wp-content/uploads/2020/05/Therm-App-MD-Pro-Brochure.pdf] • For the Therm-App MD Pro, “Up to 20 Simultaneous Scans” and “Scans multiple faces at once” [Published on your Therm-App MD Pro webpage, https://www.opgal.com/products/therm-app-md-pro] • “[T]he Therm-App MD Pro can simultaneously and passively measure multiple people's temperature” [Published in your case study about a hospital in Jerusalem, Israel, https://www.opgal.com/wp-content/uploads/2020/11/Shaare-Zedek-Case-Study-4.pdf] • “No individual measurement required.” [Published in your Therm-App MD Brochure, https://www.opgal.com/wp-content/uploads/2020/04/ThermAppMD.pdf]