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  5. Opgal Optronic Industries Ltd. - 613562 - 03/04/2021
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WARNING LETTER

Opgal Optronic Industries Ltd. MARCS-CMS 613562 —

Product:
Medical Devices
Recipient:
Recipient Name
Eran Bluestein
Opgal Optronic Industries Ltd.

PO Box 462, Industrial Area 5
Karmiel 2161401
Israel

Issuing Office:
Center for Devices and Radiological Health

United States

Opgal Optronic Industries Ltd.
PO Box 462, Industrial Area 5
Karmiel, 2161401
ISRAEL

eran.b@opgal.com - Eran Bluestein
 
RE:     Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Dear Sir,

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.opgal.com on February 22 and 25, 2021.  We have also reviewed your social media pages at https://www.youtube.com/channel/UCDKt9En7lks0xA5W3NtoLqg, https://twitter.com/OpgalLtd, and https://www.facebook.com/Opgal/ where you direct consumers to your website, https://www.opgal.com. The FDA has observed that your website offers products for measuring human body temperature, specifically the “Therm-App MD” and “Therm-App MD Pro”, for sale in the United States. Based on our review, these products are intended to mitigate, prevent, treat, diagnose or cure COVID-191   in people, and thus are devices 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 website revealed the following statements that establish that the Therm-App MD and Therm-App MD Pro are intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including:

• “Have you seen our case study about using thermal cameras to help prevent the spread of COVID-19?” [Published as a pop-up on your Therm-App MD Pro webpage, https://www.opgal.com/products/therm-app-md-pro]

• “HELP MINIMIZE THE SPREAD OF THE CORONA VIRUS OUTBREAK.” [Published in your YouTube video titled, “Therm-App MD by Opgal”, https://www.youtube.com/watch?v=2bmmXY8158I]

• “The skies are gradually opening up again, and it's time to put the ThermApp MD PRO up to the test... #airportsecurity #airport #covidsolutions #thermalimaging #thermalcameras #feverscreening” [Published your Twitter webpage, https://twitter.com/OpgalLtd/status/1310828682022453248]

• “Elevated body temperature becomes another security concern in this day and age. Opgal's thermal imaging technology has got you covered here as well… #thermalimaging #security #covid19solutions” [Published on your Facebook webpage, https://www.facebook.com/Opgal/videos/721164435451235/?__tn__=-R]

The Therm-App MD and Therm-App MD Pro are offered for sale in the United States without marketing approval, clearance, or authorization from FDA.  Accordingly, your products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your products are 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 these products 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 these products 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.2 In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.3 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 products that are 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 elevated temperature who was subject 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.opgal.com, includes statements that indicate that the Therm-App MD and Therm-App MD Pro are intended to scan multiple individuals simultaneously, including:

• For the Therm-App MD Pro, “Multiple Hotspot Detection & Tracking” [Published in your Therm-App MD Pro Brochure, https://www.opgal.com/wp-content/uploads/2020/05/Therm-App-MD-Pro-Brochure.pdf]

• For the Therm-App MD Pro, “Up to 20 Simultaneous Scans” and “Scans multiple faces at once” [Published on your Therm-App MD Pro webpage, https://www.opgal.com/products/therm-app-md-pro]

• “[T]he Therm-App MD Pro can simultaneously and passively measure multiple people's temperature” [Published in your case study about a hospital in Jerusalem, Israel, https://www.opgal.com/wp-content/uploads/2020/11/Shaare-Zedek-Case-Study-4.pdf]

• “No individual measurement required.” [Published in your Therm-App MD Brochure, https://www.opgal.com/wp-content/uploads/2020/04/ThermAppMD.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”4 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 products 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 # 613562 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 products for the mitigation, prevention, treatment,

diagnosis, or cure of COVID-19, and any appropriate correction 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.

If you are not located in the United States, please note that products that appear to be adulterated or misbranded are subject to detention and refusal of admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your products listed above to be adulterated and misbranded products that cannot be legally sold to consumers in the United States. 

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

  • 1As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
  • 2Secretary 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.
  • 3President 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/.
  • 4Accessible at https://www.fda.gov/media/137079/download.
 
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