WARNING LETTER
Cantronic Systems Inc. MARCS-CMS 613542 —
- Product:
- Medical Devices
- Recipient:
- Cantronic Systems Inc.
#8-62 Fawcett Rd
Coquitlam BC V3K 6V5
Canada-
- jzahn@cantronics.com – James Zahn
- Issuing Office:
- Center for Devices and Radiological Health
United States
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.cantronics.com on February 11, 2021. The FDA has observed that your website offers products for measuring human body temperature, specifically the FeverScan M3000N, FeverScan M3000L, LGC300 Body Temperature Scanner, FeverScan M3000B, FeverScan M3000SD, FeverScan M3000S, FeverScan M3000P02, FeverScan M3000P03, FeverScan M3000P04, and FeverScan M3000P05 (collectively,“Temperature Scanners”), 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), your Temperature Scanners are devices because they are 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.
Your Temperature Scanners 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).
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.cantronics.com/, includes statements that indicate that your Temperature Scanners are intended to scan multiple individuals simultaneously, including:
- “The FeverScan M3000N is ideal for mass temperature screening in public transport situations.” [Published on your website, https://www.cantronics.com/index.php/temperature-screening-cameras]
- “The FeverScan M3000P04 is capable of evaluating multiple people in real time” [Published on the FeverScan M3000P04 datasheet, https://www.cantronics.com/images/datasheet/FeverScan-M3000P04-.pdf]
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 613542 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.
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 product(s) listed above to be adulterated and misbranded products that cannot be legally sold to consumers in the United States.
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
CC: Dallas Thomas
FDAbasics LLC
15815 SW 11th Court Rd
Ocala, FL 34473
dallas@fdabasics.com