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 websites revealed the following statements that establish that the DuThermX is intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including: • “Fun Friday in PreFab! Two DuThermX Mobile Carts ready to be shipped out! …#covid19solutions…#covid19prevention” [Published by your Twitter account on August 21, 2020, https://twitter.com/DubakElectric/status/1296916555683561472] • “[P]roven best practices in identifying people with elevated body temperature is a key factor in mitigating the threat of illness. Recognizing the seriousness of the COVID-19 virus, Dubak’s world-class team of engineers started working on a safety solution in January 2020.” [Published on your website on April 28, 2020, https://www.duthermx.com/press-release-april]
Passage 2The DuThermX is offered for sale in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, your product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).
Passage 3Your product is 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 the product into interstate commerce for commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Passage 4Your website, https://www.duthermx.com/, includes statements that indicate that the DuThermX is intended to scan multiple individuals simultaneously, including: • “How does DuTHERMX work?” In part, the answer states the DuThermX assess “16-40 people simultaneously.” [Published on your website’s “About COVID-19” webpage, https://www.duthermx.com/coronavirus-covid19] • Chief Operating Officer Nick Dubak stated, “The DuThermX can scan 16 to 40 people at a given time.” [In a promotional video posted by Dubak Electrical Group on Vimeo, https://vimeo.com/412418206] • “BODY DETECTION, UP TO 30 TARGETS.” [Published in the “DuThermX Product Overview PDF” available on your website, https://www.duthermx.com/systems] • “BODY DETECTION, UP TO 16 TARGETS.” [Published in the “Technical Specifications” section of the “DuThermX Product Overview PDF” available on your website, https://www.duthermx.com/systems]