The U.S. Food and Drug Administration (FDA) has issued a proposed rule for the oversight of laboratory-developed tests (LDTs).
The proposed rule would make explicit in FDA regulations that LDTs are IVDs and that, as medical devices, all IVDs are overseen by the FDA under the Federal Food, Drug, and Cosmetic Act. In addition, the FDA said in a statement that it is changing its policy to phase out its "enforcement discretion approach" to LDTs and to provide more oversight of these tests.
In 2022, Congress introduced the Verifying Accurate Leading-edge IVCT Development (VALID) Act; the VALID Act would have required both IVDs and LDTs to go through FDA premarket review and for lower-risk tests to be allowed on the market after passing technological certification.
The proposed act met with some industry opposition, and Congress failed to pass it. The FDA subsequently announced that it would seek to regulate LDTs under its existing authority, a move supported by some advocacy groups.
Nevertheless, the FDA’s proposal has met with opposition. Following the FDA’s announcement of the rule on Friday, the American Clinical Lab Association (ACLA) issued a statement expressing its opposition to the proposed rule, noting that “ACLA has long taken the position that FDA does not have statutory authority to regulate LDTs under its medical device authority and strongly opposes unilateral action that exceeds the Agency’s current authority.”
The FDA is taking comments from the public on the proposed rule beginning October 2, 2023, through December 1, 2023.