On April 29, 2024, the FDA took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of healthcare decisions and about which concerns have been raised for many years. The FDA announced a final rule today amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Historically, the FDA has generally exercised enforcement discretion for most LDTs, meaning that the agency has not enforced applicable requirements concerning most LDTs. Now, many LDTs are widely used for a larger and more diverse population, with large laboratories accepting specimens from across the country. The FDA is aware of numerous examples of potentially inaccurate, unsafe, ineffective, or poor quality IVDs offered as LDTs that caused or may have caused patient harm. “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. @ https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests?utm_medium=email&utm_source=govdelivery
