FDA Proposes New Rule on Who has Oversight on Lab Tests

October 3, 2023

Citing a continued dramatic growth in the use of laboratory-developed tests (LDT) over the past two decades, the FDA Friday announced a proposed rule that would bring the tests under the agency’s purview, trying a new route to put to rest the decades-long debate over who should provide oversight.

The CDC estimates that 70 percent of today’s medical decisions depend on laboratory test results. Those statistics underscore the high stakes of this issue from multiple angles.

According to the proposal, the FDA is amending its regulations to make explicit that in vitro diagnostic products (IVD) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act including when the manufacturer of the IVD is a laboratory.

The deadline for public comment is Dec. 4.

Read the proposed rule here.

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