WARNING LETTER
Dubak Electrical Group
MARCS-CMS 613511 —
March 04, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Vlastimir Dubak
Dubak Electrical Group
10 Beach Avenue
LaGrange
,
IL
60526
United States
vdubak@dubakelectrical.com
Issuing Office:
Center for Devices and Radiological Health
United States
Dubak Electrical Group
10 Beach Avenue
LaGrange, Illinois 60526
vdubak@dubakelectrical.com - Vlastimir Dubak
Dear Sir,
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 websites at the Internet addresses https://www.duthermx.com/ and https://www.dubakelectrical.com/ on February 12, 2021. We have also reviewed your social media pages at https://twitter.com/DubakElectric, and https://vimeo.com/user101578125 where you direct consumers to your website, https://www.dubakelectrical.com, which contains a link to https://www.duthermx.com. The FDA has observed that your website offers a product for measuring human body temperature, specifically the “DuThermX”, for sale in the United States. Based on our review, the this product is intended to mitigate, prevent, treat, diagnose or cure COVID-19
1
in people, and thus is a device under section 201(h) of the Federal, Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).
FDA’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]
The 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). 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 Presidential 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, the 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 elevate temperature who was subect to 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, 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]
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 # 613511 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
1
As explained below, there is currently an outbreatk of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
2
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.
3
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