HHS Withdraws Rescission of FDA Authority to Regulate Lab-Developed Tests

Stacy Cline Amin spoke to BioWorld about the U.S. Department of Health and Human Services withdrawing its rescission of the Food and Drug Administration’s (FDA) authority to regulate lab-developed tests (LDTs), a reversal predicated on the need for additional testing capacity for the COVID-19 pandemic.

According to Stacy, the withdrawal of the rescission order has been anticipated for several months. “I recall from serving during a presidential transition year, everything feels like an emergency to the people working on it, but at the leadership of the organization, they are triaging from every direction,” she said, adding that the associated FDA update “took a long time to develop and get through clearance” as demonstrated by the level of detail.

Stacy said she expects that the developers of “a large number of LDTs” for the pandemic will have to cease marketing if they want to avoid a confrontation with the FDA. However, she predicted that this is likely to be limited to “tests that are not validated and pose a risk of providing false results, or tests that do not contribute significantly to overall testing capacity.”

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