WARNING LETTER
Omega Engineering Inc.
MARCS-CMS 613560 —
March 04, 2021
Product:
Medical Devices
Recipient:
Omega Engineering Inc.
800 Connecticut Avenue
Norwalk
,
CT
06854
United States
Issuing Office:
Center for Devices and Radiological Health
United States
Omega Engineering Inc.
800 Connecticut Avenue
Suite 5N01
Norwalk, Connecticut  06854
tliu@omega.com - Ting Liu
Dear Sirs,
RE:     Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.omega.com/ on February 19, 2021. We have also review your social media page at https://www.youtube.com/channel/UC9bRLkDgDpxM9JdluFlW3Eg where you direct consumers to your website, www.omega.com. The FDA has observed that your website offers a product for measuring human body temperature, specifically the “TI-120GTS”, for sale in the United States. Based on our review, this product is intended to mitigate, prevent, treat, diagnose or cure COVID-19
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in people, and thus is a device under section 201(h) of the Federal, Food, Drug, and Cosmetic Act (the “Act”) .
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]
This TI-120GTS 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). 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). The introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a).
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.
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In addition, on March 13, 2020, the Presidentl declared a national emergency in response to COVID-19.
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[ ] Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval, clearance, or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described herein, you offer for sale a product that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people. We request that you take immediate action to cease the sale of such adulterated and misbranded products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Use of telethermographic devices for the assessment of human body temperature can present potentially serious public health risks. Such risks may include, but are not limited to, whether a device incorrectly detecting a normal human body temperature when a person has an elevated temperature and incorrectly assessing a person to have an elevated body temperature when they do not. A person with an undetected elevated temperature who was subject to a temperature assessment using a telethermographic device may, as a result, be less likely to adhere to infection prevention and control guidelines, such as social distancing and using personal protective equipment. These risks are more likely to be present where telethermographic devices scan multiple individuals simultaneously. 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 more information about FDA’s regulation of devices used to mitigate, prevent, treat, diagnose, or cure COVID-19; frequently asked questions; and other helpful resources, visit our website at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/coronavirus-covid-19-and-medical-devices. In addition, the guidance titled “Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency”
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[ ] provides information about FDA’s policies intended to help expand the availability of telethermographic systems used for body temperature measurements for triage use during the COVID-19 public health emergency.
You should take action to address the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your product(s) as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that misbrand the products in violation of the Act. Within 48 hours, please send an email to
COVID-19-Task-Force-CDRH@fda.hhs.gov
describing the specific steps you have taken to address these violations, using CMS # 613560 as reference. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address any violations may result in legal action, including, without limitation, seizure and injunction.
FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and are being misleadingly represented as safe and/or effective for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the Act. This list can be found at https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products. Once you have taken actions to address the sale of unapproved, uncleared, and unauthorized product(s) for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.
This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please direct any inquiries to FDA at
COVID-19-Task-Force-CDRH@fda.hhs.gov
.
Sincerely,
/S/
Courtney H. Lias, Ph.D.
Acting Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
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As explained below, there is currently an outbreatk of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
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Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
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President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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Accessible at https://www.fda.gov/media/137079/download.
Content current as of:
03/04/2021
Regulated Product(s)
Medical Devices