The policy change has been a major point of tension for weeks between HHS and FDA.
The Trump administration will allow coronavirus tests developed by individual laboratories — including commercial facilities run by Quest Diagnostics and LabCorp — to be used without an FDA review, a decision that public health experts warn could lead to broad use of flawed tests.
The Department of Health and Human Services outlined the decision in a notice published Wednesday.
The majority of coronavirus tests used now in the U.S. are made by device manufacturers, who still must seek FDA permission to market their products. But the lab-developed tests affected by the new policy are also in wide use. Continue reading.