Key Takeaways from FDA’s Final Rule on Laboratory-Developed Tests

Lexology May 6, 2024
Morgan, Lewis & Bockius LLP

The US Food and Drug Administration (FDA) on April 29, 2024 announced its Final Rule on laboratory-developed tests (LDTs). This marks the beginning of the end of FDA’s broad and long-established enforcement discretion policy for LDTs, under which most LDTs were not expected to meet the premarket or postmarket regulatory requirements. The Final Rule makes clear that LDTs are now considered regulated medical devices and that FDA will phase out its LDT enforcement discretion policy over a four-year period.

This LawFlash discusses the key takeaways from the LDT Final Rule, FDA’s phaseout policy for LDT enforcement discretion, and potential consequences.

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