From Discretion to Regulation: What FDA’s Final Rule Means for Laboratory Developed Tests
Hall Render
JUNE 5, 2024
Stage 4: Effective November 6, 2027 Approximately three and a half years after the publication of the Final Rule, high-risk (Class III) IVDs offered as LDTs must comply with premarket review requirements. The FDA notes that it will continue to exercise enforcement discretion during the review of premarket submissions received by this stage.
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