Per the notice below, the United States Food and Drug Administration (FDA) has issued a final rule on the safety and effectiveness of laboratory developed tests and is holding a free Webinar explaining the final rule.

FDA Takes Action to Help Ensure the Safety and Effectiveness of Laboratory Developed Tests

“Today’s action is a critical step toward helping to ensure the safety and effectiveness of LDTs, while also taking into account other public health considerations, including continued access to critical tests patients rely upon,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Laboratory developed tests, or LDTs, can play an important role in healthcare.  LDTs are in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meets the regulatory requirements under CLIA to perform high complexity testing.  Today, the U.S. Food and Drug Administration (FDA) announced a final rule amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory.  Along with this amendment, the FDA outlined a policy to phase out, over the course of four years, its general enforcement discretion approach to LDTs.  The agency also outlined targeted enforcement discretion policies for certain categories of tests manufactured by laboratories.

The FDA considered the large volume of comments received to the notice of proposed rulemaking, and adjusted the phaseout policy in a manner that best serves the public health.  The FDA believes that phasing out its general enforcement discretion approach for most LDTs over a period of four years will better protect the public health by helping to assure the safety and effectiveness of these tests, while avoiding undue disruption to patient care.  Better assuring the safety and effectiveness of LDTs also may foster test innovation and facilitate the collective efforts of the scientific and medical communities to identify promising technologies, new therapies, or areas worthy of future research.  After this phaseout, the FDA generally will expect IVDs made by either a non-laboratory or laboratory to meet the same requirements, though certain IVDs manufactured by laboratories may fall within one of the agency’s target enforcement discretion policies.  With increased oversight, the FDA will also be able to help promote adequate representation in validation studies, as well as transparency regarding potential differential performance and unknown performance in certain patient populations, which may ultimately help advance health equity.

Upcoming Webinar on this rule

On May 14, 2024, the FDA will host a webinar to provide an overview of the final rule and phaseout policy.

• If you have questions about this final rule that you wish to submit for possible discussion during the Webinar, please e-mail: CDRHWebinars@fda.hhs.gov.
• All questions must be received by May 7, 2024, to be considered for the discussion.  Questions will be not be taken during the live Webinar.
• Following this, the FDA intends to announce additional Webinars on specific topics related to the phaseout policy and the targeted enforcement discretion policies.

Questions?