WARNING LETTER
Kogniz, Inc.
MARCS-CMS 613569 —
March 04, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Jed Putterman
Kogniz, Inc.
225 Miller Avenue Building B
Mill Valley
,
CA
94941
United States
jed@kogniz.com
Issuing Office:
Center for Devices and Radiological Health
United States
Kogniz, Inc.
225 Miller Avenue Building B
Mill Valley, California  94941
jed@kogniz.com – Jed Putterman
RE:     Adulterated and Misbranded Products
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.kogniz.com/ on February 12, 2021. The FDA has observed that your website offers a product for measuring human body temperature, specifically the “KOGNIZ TC20”, for sale in the United States. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h), the KOGNIZ TC20 is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Telethermographic systems are devices when they are intended for a medical purpose, such as body temperature measurement, including such use in non-medical environments.
The KOGNIZ TC20 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).
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.kogniz.com/, includes statements that indicate that the KOGNIZ TC20 is intended to scan multiple individuals simultaneously, including:
•  “Large groups of people get screened at the same time.” [Published on your website, https://www.kogniz.com/]
• “Accurately measure body temperatures of groups of people entering a building.” [Published on your website, https://www.kogniz.com/]
Your firm should take prompt action to correct any violations. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
This letter notifies you of our concerns and provides you with an opportunity to address them. After you receive this letter, please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct any violations, as well as an explanation of how your firm plans to prevent their recurrence.
Your response should include documentation of the corrections and/or corrective actions (including those that address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your firm’s response should be sent to:
Attn: CAPT Alan Stevens
Acting Director, Division of Drug Delivery and General Hospital Devices,
and Human Factors
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Office of Product Evaluation and Quality
OHT3: Office of GastroRenal, ObGyn, General Hospital, and Urology Devices
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Refer to the reference number CMS 613569 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Jake Lindstrom, PhD at
Jake.Lindstrom@fda.hhs.gov
or (301( 796-5716.
Finally, you should know that this letter is not intended to be an all-inclusive list of the 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.
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
Content current as of:
03/04/2021
Regulated Product(s)
Medical Devices