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FDA Discusses Registration and Listing Rules for LDTs

Dec 10, 2024

On December 3, the FDA led a webinar reviewing compliance for its registration and device listing requirements for laboratory-developed tests (LDTs). These requirements are part of stage 2 of the FDA LDT oversight regulation and take effect May 2026. Stage 1 requirements take effect May 6, 2025.

The CAP had previously urged the FDA to provide more education about the agency’s process for registration and listing how the process would apply to LDTs.

Review the FDA webinar slides and webpage.

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