Comment on FDA’s Proposed Rule on Laboratory-Developed Tests (LDTs)

Comment on Proposed Rule re: Medical Devices; Laboratory Developed Tests (Docket No. FDA-2023-N-2177)

The undersigned individuals appreciate FDA’s efforts to regulate laboratory-developed tests (LDTs) with the proposed rule titled Medical Devices; Laboratory Developed Tests. This proposed rule addresses a complicated and important issue by providing a straightforward solution. In sum, the proposed rule makes explicit that all in vitro diagnostic tests (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including when the manufacturer is a laboratory. It also proposes a policy to phase out its current enforcement discretion approach for LDTs, meaning that LDTs would generally fall under the same riskbased enforcement approach as other diagnostic tests. FDA regulation of LDTs will ensure that patients and doctors are getting results that are accurate and clinically meaningful.