Partner Dennis Gucciardo is featured in a Medtech Insight article about the likelihood that the US Food and Drug Administration (FDA) will finalize a proposal to regulate lab-developed tests (LDT) as medical devices by April 2024. Dennis said he expects the agency to move quickly through comments to publish a final rule ahead of a possible presidential turnover in 2025 and that there is still a chance that Congress will address LDT regulation through the Verifying Accurate Leading-edge IVCT Development (VALID) Act.
“One of the thought processes behind the FDA being so aggressive with the LDT rule is maybe that will finally light Congress's fire to authorize the VALID Act,” Dennis said.
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