HHS Lab Test Rule’s Likely Impact During And After COVID-19

On Aug. 19, the U.S. Department of Health and Human Services published a brief announcement on its website that the U.S. Food and Drug Administration, an agency within HHS, will not require premarket review of laboratory-developed tests, absent notice-and-comment rulemaking.

The announcement — published without fanfare on a subsection of the HHS website devoted to coronavirus testing information and without any corresponding press release or Federal Register notice — reflects a substantial policy reversal with significant implications for the FDA’s regulation of laboratory-developed tests in the context of the COVID-19 public health emergency and more generally.