In Bloomberg Law, Greg Levine Discusses Scrutiny of FDA Proposed Regulation of Laboratory-Developed Tests

In a Bloomberg Law article, Greg Levine, partner and chair of the firm’s global FDA regulatory group, discussed the scrutiny to a proposed rule that would bring laboratory-developed tests under the authority of U.S. Food and Drug Administration.

If finalized in its current form, the FDA could regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act, requiring the products to undergo additional rigorous review before being marketed.

Greg explained that Congressional actions to give the FDA added power stalled in 2022 when the Verifying, Accurate, Leading-Edge IVCT Development (VALID) Act was dropped. “This action by FDA is essentially a challenge to Congress to act. It’s like throwing down the gauntlet to Congress and saying, if you don’t act, we are going to act on our own,” said Greg.