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FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests

NEW YORK – The US Food and Drug Administration on Friday issued a proposed rule for oversight of laboratory developed tests (LDTs).

The rule would amend FDA regulations to make explicit that LDTs are in vitro diagnostics (IVDs) and that all IVDs are medical devices and therefore overseen by FDA under the Federal Food, Drug, and Cosmetic Act.

Additionally, FDA said it is changing agency policy to phase out what it described as an "enforcement discretion approach" to LDTs and to provide greater oversight of these tests.

LDT regulation has come to the fore in recent years, with, in 2022, Congress making one of its most serious attempts to date to pass legislation giving oversight of these tests. Called the Verifying Accurate Leading-edge IVCT Development (VALID) Act, the bill would have created a risk-based framework for what it termed in vitro clinical tests (IVCTs) — which would include both IVDs and LDTs — with high-risk tests, such as novel assays, required to go through FDA premarket review and lower-risk tests allowed on the market after passing through technological certification.

Following Congress' failure to pass VALID last year, the FDA announced it would seek to regulate LDTs under its existing authority.

The agency's proposed rule will face opposition from many in the lab and diagnostics business. Following announcement of the rule on Friday, the American Clinical Lab Association issued a statement opposing the rule, noting that it 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."

AdvaMed President and CEO Scott Whitaker said in a statement that the organization is evaluating the proposed rule and urged Congress to return to consideration of legislation like VALID that he said would have "accomplished a long-overdue modernization of the regulatory framework for diagnostics."

The public can submit comments on the proposed rule between Oct. 2, 2023, and Dec. 1, 2023.