Legal Experts: HHS Policy Change Strips FDA Of Oversight For All LDTs

Last week’s policy statement from HHS is “a broader directive wrapped in a COVID sandwich,” one attorney says

Three lawyers tell Medtech Insight that the recent move by the US HHS to revoke the FDA’s authority to oversee laboratory developed tests extends to all LDTs, and not just those used to test for COVID-19.

A young Asian woman scientist working in laboratory with test tube microscope and solutions.

A week-old policy statement from the US Department of Health and Human Services that stripped the Food and Drug Administration of its oversight of laboratory developed tests indeed applies to all LDTs and not just those for COVID-19, legal experts tell Medtech Insight.

While the HHS announcement refers to the coronavirus pandemic three times, the core policy declaration – the FDA “will not require premarket review of laboratory developed tests absent notice-and-comment rulemaking,...

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