Congressional leaders are disappointed with the U.S. Food and Drug Administration final rule on the regulation of in vitro diagnostic tests (IVDs), including laboratory-developed tests (LDTs).

The final rule amends existing regulations regarding LDTs, defined by the FDA as IVDs intended for clinical use and designed, manufactured, and used within a single clinical laboratory. Under the rule, all IVDs are designated as medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.

“While the final rule is a slight improvement to the proposed rule, it will still increase costs and decrease access to diagnostics and medical tests that provide information crucial for doctors to treat their patients effectively,” House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) said in a statement. “The FDA should abandon the rule, as it lacks the clear statutory authority to implement it.”

Congress has yet to pass the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2023 (H.R. 2369), which would provide an alternative regulatory framework to the FDA for IVDs. The bill was reintroduced in the House on March 29, 2023, by Reps. Larry Bucshon, M.D. (R-Ind.) and Diana DeGette (D-Colo.). It was subsequently referred to the Committee on Energy and Commerce and Committee on Ways and Means to consider specific provisions of the bill.

“Rational oversight of in-vitro diagnostics, including laboratory-developed tests, is vital for innovation in diagnostics and public health. We are disappointed that the FDA has moved ahead with a burdensome rule based on an inflexible statute that was never designed to regulate in vitro diagnostics,” Reps. Bucshon and DeGette said in a joint statement. “However, we also recognize that FDA’s action today is because Congress hasn’t acted yet. Congress has not given FDA the tools it needs to appropriately carry out its public health mission.

“With innovative test makers, medical centers, and labs that are the backbone of diagnostics in the U.S. now facing this burdensome regulation, we must come together and pass our VALID Act. The tiered, risk-based approach to in-vitro test oversight we have developed would protect patients and spur diagnostic innovation. We can create a rational oversight system for in-vitro tests, and we owe it to the patients of today and tomorrow to get this right.”

The final rule is effective July 5, 2024, and is now publicly accessible in the Federal Register.