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The federal agency issued warning letters to Certify Global Inc., Kogniz Inc., Opgal Optronic Industries Ltd., and Thermavis.
March 5, 2021
1 Min Read
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FDA is alerting the public that improper use of thermal imaging systems intended to measure the human body temperature may provide inaccurate temperature readings due to a variety of factors.
These devices are known as telethermographic systems, infrared thermographs, thermal cameras, and "fever cameras.” FDA issued several Warning Letters to Certify Global Inc., Kogniz Inc., Opgal Optronic Industries Ltd. and Thermavis.
"While thermal imaging is not an effective diagnostic device for COVID-19, it can determine if someone has an elevated temperature, which can be an important risk management tool during the pandemic when used properly," said William Maisel, MD, MPH, Chief Medical Officer and director of the Office of Product Evaluation and Quality in FDA's Center for Devices and Radiological Health. "But improper use and marketing of thermal imaging systems may lead to inaccurate temperature readings and pose a potential danger to public health. As part of FDA's ongoing commitment to transparency to the American public, the agency is providing important information to users about the correct use of these devices and is warning certain firms that FDA will not tolerate their marketing of misbranded and adulterated products."
FDA said it is aware that thermal imaging systems can be used as a way to detect temperature as part of a larger approach to COVID-19 risk management, such as in combination with mask wearing, social distancing and hand washing, to provide initial temperature assessments or triage individuals for elevated temperatures in public areas such as airports, grocery stores, offices and schools. FDA said when designed and used correctly, thermal imaging systems have been shown to accurately measure someone's surface skin temperature.
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