Q&A: FDA’s LDT Inaction Catches Veteran Attorney Off-Guard
Industry experts expected the US FDA to swiftly reverse a Trump-administration policy blocking oversight of lab-developed tests. Its inaction has one former agency attorney wondering why.
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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.