FDA Finalizes Rule Regulating Laboratory Developed Tests

FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal Register yesterday, May 6, 2024. This follows a decades-long effort by some stakeholders to clarify the regulatory status of these tests. This landmark rule was finalized with lightning speed, with the Proposed Rule published in the Federal Register on October 2, 2023….
By: Polsinelli
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