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Reclassification to higher risk category was years in the making

[author: Heather Hatcher, Ph.D.] A year into the current public health emergency, the FDA’s Center for Devices and Radiological Health (CDRH) announced on Thursday, April 15, 2021, that the center is “prioritizing and triaging our work using existing resources in order to focus on our COVID-19 response, resulting in delays in some other work areas.” Dr. Jeff Shuren, Director, CDRH, and Dr. William Maisel, Director, Office of Product Evaluation and Quality at CDRH, reported that the astounding numbers of pre-EUA and EUA submissions received for COVID-19 tests and collection kits created ...

FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale News provided by Share this article Share this article SILVER SPRING, Md., March 4, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration today 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...

FDA alerts consumers about improper use of thermal imaging systems, warns firms for marketing unapproved devices The U.S. Food and Drug Administration today 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, an...

U.S. COVID-19 death toll tops 520,000 as Dr. Fauci cautions against reopening too soon MarketWatch 3/5/2021 CORONAVIRUS UPDATE The U.S. death toll from the coronavirus-borne illness COVID-19 climbed above 520,000 on Friday, as Dr. Anthony Fauci became the latest health expert to slam state officials for prematurely dropping restrictions on movement at a time when their case numbers remain high and their vaccine programs are making slow progress.  “I don’t know why they’re doing it but it’s certainly, from a public health standpoint, ill-advised,” Fauci, head of the National Insti...