NILA and AAB Comment on FDA’s Proposed LDT Rule

On October 3, 2023, the Food and Drug Administration (FDA) published a proposed rule, Medical Devices; Laboratory Developed Tests, that would amend regulations indicating that in vitro diagnostic tests (IVDs) are medical devices, including when the manufacturer of the IVD is a laboratory. This policy change, if finalized, would require the regulation of laboratory developed tests (LDTs) under the purview of the FDA.

On December 4, 2023, NILA and AAB submitted comments to FDA Commissioner Robert M. Califf, M.D., in response to the FDA’s proposed rule. NILA and AAB strongly object to the FDA’s approach to the regulation of LDTs and cannot support the proposal in its current form. The proposed rule asserts that LDTs are medical devices and should therefore be regulated under the same framework as all other medical devices. LDTs are not medical devices and should not be regulated as such. In addition, laboratories are not commercial manufacturers.

If implemented, the FDA's proposed rule would have serious consequences on patients, providers, and laboratories. The proposed rule will place undue administrative and financial burden on laboratories at a cost that will stifle innovation and will jeopardize certain aspects of patient care. The proposed regulatory requirements will cause many laboratories to drop tests from their test menus, leaving a gap in patient access to testing at a time when patient access to testing is essential.

LDTs identify new and dangerous substances during the current national drug abuse crisis; identify emerging infectious diseases; and provide a myriad of clinically important information needed in the interest of public health. For many LDTs, there is no comparable IVD test kit—and contrary to the assertion made by the FDA in the narrative, the changes proposed will not spur innovation from traditional medical device manufacturers to fill those gaps. NILA and AAB strongly urge the FDA to withdraw the proposed rule, and instead collaborate with stakeholders and policymakers to develop a solution that works for everyone, including a solution that acknowledges the unique nature of LDTs and prioritizes patient access to LDTs.

Quick Links

NILA and AAB Comment on FDA’s Proposed LDT Rule – 12/4/23 Letter to FDA Commissioner Robert M. Califf, MD (PDF)

FDA/HHS Proposed Rule, Medical Devices; Laboratory Developed Tests, 10/3/23 Federal Register (PDF)

FDA News Release, 9/29/23 – FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of LDTs