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FDA Warning Letter Explorer
Medical Devices · Mar 4, 2021

Omega Engineering Inc.

4 extracted findings

FDA source excerpt, selected passage

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).

FDA published a close-out letter on Jul 27, 2023. The findings below are from the original warning letter.

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
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).
02
Your 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).
03
FDA’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]
04
Your 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]

For background, see Premarket notification (510(k)). Explore Botable’s work in Medical devices.

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