On September 29, 2023, the U.S. Food and Drug Administration (FDA) unveiled a proposal for a new rule concerning the regulation of laboratory developed tests (LDTs). If the proposal is passed, changes would be made to the FDA’s existing regulations to make it explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act, including instances when the manufacturer of the IVD is a laboratory.
The Federal Food, Drug, and Cosmetic Act is a vital piece of legislation that empowers the Agency to enforce premarket approval requirements for “devices,” which would now include IVDs. This proposed rule change is an indication of how seriously the FDA is taking the necessity of regulating LDTs.
The proposal does not outline an immediate change, but rather, suggests a phased approach to regulating LDTs. This strategy is likely to give manufacturers and laboratories sufficient time to adapt to the new regulations if they were to be enacted.
This latest proposal from the FDA forms part of ongoing dialogues around how best to regulate LDTs in a manner that effectively prioritizes patient safety while fostering innovation in the medical field.
For further details on the proposal, you can review the full document on the agency’s website. It’s noteworthy to mention that the proposal does not represent fixed plans and could undergo changes following periods of comments and revisions.
For a detailed read on the FDA’s proposal, you can visit Goodwin on JD Supra.