FDA Proposes Rule to Enhance Safety and Effectiveness of LDTs

October 03, 2023 By: Quadax

The FDA has proposed regulating laboratory-developed tests to align them with other in vitro diagnostics.

12/6/2023 UPDATE: The FDA plans to finalize the proposed rulemaking on laboratory-developed tests (LDTs) by April 2024. (source: CAP)

The US Food and Drug Administration has unveiled a proposed rule to enhance supervision of laboratory developed tests (LDTs). 

In an effort to reinforce regulations, the FDA is putting forth the proposal to explicitly state that in vitro diagnostics (IVDs) are considered devices under the Federal Food, Drug, and Cosmetic Act, even when manufactured by laboratories. 

While the FDA has typically exercised leniency in enforcing regulations for most LDTs, there is growing concern that some may not deliver accurate results or perform as effectively as FDA-approved tests and those that comply with FDA standards.

Drawing on its recent experience in the rapid development of COVID-19 diagnostics and the emergence of companion tests connecting cancer patients with specific drug treatments, the FDA highlights the similarity between many laboratory-developed test systems and more regulated IVD. 

“A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions,” said FDA Commissioner Robert M. Califf, M.D. “According to the Centers for Disease Control and Prevention, 70% of today’s medical decisions depend on laboratory test results. Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health.”

The proposed rule put forth by the FDA is expected to face significant opposition from various stakeholders in the lab and diagnostics industry. In response to the announcement, the American Clinical Lab Association has issued a strong statement expressing their opposition to the rule. They plan to submit comments urging the FDA to reconsider and instead work collaboratively with Congress, the laboratory community, patient groups, and other stakeholders to develop a legislative solution that takes into account the unique attributes of LDTs.

Under the new proposal, FDA would gradually phase in tighter regulation of lab tests over five years. The agency is considering exempting some existing tests already on the market from review but is seeking public input on its approach. At the end of the process, most new tests would be subject to FDA standards and regulatory review before launching.

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



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