WARNING LETTER
Omnisense Systems Pte Ltd.
MARCS-CMS 613561 —
March 04, 2021
Product:
Medical Devices
Recipient:
Omnisense Systems Pte Ltd.
8 Penjuru Lane
609189
Singapore
Issuing Office:
Center for Devices and Radiological Health
United States
Leonard Lim
Omnisense Systems Pte Ltd
8 Penjuru Lane,
609189
SINGAPORE
Leonard Lim
Omnisense Systems USA Inc
1881-1887 West State Road 84,
Bldg. 1 Unit 102, Fort Lauderdale,
Florida 33315
USA
enquiries@omnisense-systems.com
enquiries@omnisense-systems.com
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.omnisense-systems.com/ on February 18, 2021. The FDA has observed that your website offers a product for measuring human body temperature, specifically the Sentry MK4, for sale in the United States. Based on our review, this product is intended to mitigate, prevent, treat, diagnose or cure COVID-19
1
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 Sentry MK4 is intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including:
• “From H1N1, MERS, Ebola and now COVID-19, our fever detection system have been the trusted solution to secure critical installations and national borders.” [Published on your website, https://www.omnisense-systems.com/]
• “Drawing on our proven performance of Sentry MK3, the system that protected many organizations and institutions from H5N1 to COVID-19, the Sentry MK4 is a culmination of more than a decade experience of developing a remarkable fever screening system.” [Published in the Sentry MK4 Brochure available on your Sentry MK4 webpage, https://www.omnisense-systems.com/products/sentry-mk4-mass-fever-screening-system/]
• “At the forefront of pandemic defence, the Sentry MK4 Mass Fever Screening System stands guard against infectious diseases and viruses. Already deployed in commercial buildings, industrial plants, airports, hospitals, banks and other critical facilities, the Sentry MK4 is an essential security solution for any modern organization seeking to safeguard human assets and sustain business operations during a pandemic outbreak.” [Published in the Sentry MK4 Brochure available on your Sentry MK4 webpage, https://www.omnisense-systems.com/products/sentry-mk4-mass-fever-screening-system/]
The Sentry MK4 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 this 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 President 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 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.omnisense-systems.com/, includes statements that indicate that the Sentry MK4 is intended to scan multiple individuals simultaneously, including:
• “Mass Fever Screening System” [Published in numerous places on your website, such as your Sentry MK4 webpage, https://www.omnisense-systems.com/products/sentry-mk4-mass-fever-screening-system/]
• “Sentry MK4 – Mass Fever Screening System scans, detects and tracks febrile persons with elevated skin temperature at any venue with large human traffic” [Published on your Sentry MK4 webpage, https://www.omnisense-systems.com/products/sentry-mk4-mass-fever-screening-system/]
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 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 # 613561 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 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.
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
CC:
Andrew Southern
Invisible Health Technologies
520 West 27th St.Suite 407
New York, NY 10001
andrew@invisiblehealthtechnologies.com
Andrew Southern
Invisible Health Technologies
3250 NE 1st Ave, Suite 305
Miami, FL 33137
andrew@invisiblehealthtechnologies.com
Adam Lim
Native Instinct LLC
3206 Canal Drive,
Boynton Beach, FL 33435
adam@nativeinstinct.co
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As explained below, there is currently an outbreak 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