ACLA Urges FDA to Withdraw Proposed Rule to Regulate Laboratory Developed Tests

September 01, 2020 Categories:

In December 2023, ACLA submitted comments urging the FDA to withdraw its proposed rule to regulate laboratory developed tests (LDTs) as medical devices. FDA’s proposed rule, if finalized, would jeopardize the ongoing ability of laboratories to develop and offer innovative LDTs essential to delivering the latest scientific advances in diagnostics to patient care.

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