The FDA's Laboratory Land Grab
The agency wants to treat academic and other lab tests like medical devices. It’s a lousy idea, and probably illegal.
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The agency wants to treat academic and other lab tests like medical devices. It’s a lousy idea, and probably illegal.
Today, the U.S. Department of Health and Human Services (HHS) announced new Guidance that specifies what additional data must be reported to HHS by laboratories along with Coronavirus Disease 2019 (COVID-19) test results.