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Food and Drug Administration and Compliance Issues
Wednesday, May 13, 2020
Coronavirus (COVID-19) Update: Daily Roundup May 13, 2020
The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:
The FDA announced that the agency will host a virtual Town Hall on May 15, 2020, for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 public health emergency. This is a collaboration between the FDA, the Department of Veterans Affairs’ Innovation Ecosystem, and the National Institutes of Health’s 3D Print Exchange.
Today, the FDA posted a new webpage with information on use of thermal imaging systems. Thermal imaging systems and non-contact infrared thermometers use different forms of infrared technology to measure temperature. When used correctly, thermal imaging systems generally have been shown to accurately measure someone’s surface skin temperature without being physically close to the person being evaluated.
During the COVID-19 pandemic, the FDA has worked with more than 390 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
To date, the FDA has authorized 95 tests under EUAs, which include 82 molecular tests, 12 antibody tests, and 1 antigen test.