Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Accordingly, 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 2Your 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 3FDA’s review of your website revealed the following statements that establish that the TI-120GTS is intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including: • “Public officials and healthcare providers are already relying on these tools to fight the ongoing COVID-19/Coronavirus pandemic.” [Published on your website, https://www.omega.com/en-us/resources/ir-human-temperature-measurement] • “Group temperature screening for elevated body temperature (or EBT) is becoming the “new normal” in the wake of the COVID-19 pandemic.” [Published by your firm on YouTube, https://www.youtube.com/watch?v=J-RuGNOpgUg] • “Group temperature screening adds a layer of defense against the spread of infectious diseases like COVID-19” [Published by your firm on YouTube, https://www.youtube.com/watch?v=UV4jRmpUZ9g]
Passage 4Your website, http://omega.com/, includes statements that indicate that the TI-120GTS is intended to scan multiple individuals simultaneously, including: • “Group Screening Thermal Imager”, “Group Temperature Screening Thermal Imaging with Face Detection”, “Face detection technology allows for multiple people to be screened simultaneously”, “The TI-120GTS is a unique thermal camera that allows for group temperature screening”, and “accurately measuring the temperature of large groups” [All statements published on your TI-120GTS webpage, https://www.omega.com/en-us/temperature-measurement/noncontact-temperature-measurement/human-temperature-measurement/p/TI-120GTS-Series] • “Omega’s TI-120GTS Series thermal imaging system offers the perfect solution for group body temperature screening” and “Group Temperature Screening | Thermal Imaging (TI-120GTS)” [Both statements published on YouTube, https://www.youtube.com/watch?v=UV4jRmpUZ9g] • “The TI-120GTS-Series thermal imager…is perfect for single and multi-person human body temperature screening” and “multiple people to be screened simultaneously” [Both statements published in your TI-120GTS Specifications Sheet, https://assets.omega.com/spec/TI-120GTS%20Spec%20Sheet.pdf]