March 4, 2021
The U.S. Food and Drug Administration alerted consumers, health care providers, and other users of thermal imaging systems intended to measure human body temperature—also known as telethermographic systems, infrared thermographs, thermal cameras, and “fever cameras”—that improper use of the systems may provide inaccurate temperature readings due to a variety of factors. Additionally, the FDA issued several Warning Letters to certain firms offering unapproved, uncleared, and unauthorized thermal imaging systems for sale.
“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, M.D., M.P.H., 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 the 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 the FDA will not tolerate their marketing of misbranded and adulterated products.”
Thermal imaging systems intended to measure a person’s surface skin temperature are regulated as devices by the FDA. Thermal imaging systems detect infrared light emitted from a person’s skin and convert that information into a temperature reading. The FDA 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 handwashing, to provide initial temperature assessments or triage individuals for elevated temperatures in public areas such as airports, grocery stores, offices, and schools. When designed and used correctly, thermal imaging systems have been shown to accurately measure someone’s surface skin temperature.
Improper use of thermal imaging systems may lead to inaccurate body temperature measurements which 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. These risks are more likely to be present where thermal imaging systems scan multiple individuals simultaneously. To help mitigate these risks, the FDA is providing important recommendations in the safety communication to consumers, health care providers, and other users about the proper and improper use of these systems. The FDA is also aware that some firms are marketing unapproved, uncleared, and unauthorized thermal imaging devices intended to measure human body temperature, including measuring multiple individuals’ temperatures simultaneously, and has issued Warning Letters to Certify Global Inc., Kogniz Inc., Opgal Optronic Industries Ltd., and Thermavis The FDA’s position is that Warning Letters are issued only for violations of regulatory significance. Warning Letters that have been issued by the FDA are published on Warning Letters page, and COVID-19 related Warning Letters are published on FDA’s Fraudulent Coronavirus Disease 2019 (COVID-19) Products page.