In a move that has indeed led to many discussions, the Food and Drug Administration (FDA) released a final rule on September 18 that cancels one from 2024, which applied medical device rules to the laboratory-developed tests – LDTs. The final rule happens to be in response to a March 31, 2025, federal district court decision, which also went ahead and vacated the 2024 final rule of the FDA. The AHA had previously asked the FDA to not apply its 2024 final rule to the hospital and health system LDTs when it got proposed.
According to AHA director of outpatient payment, emergency readiness, and public health policy, Roslyne Schulman, the AHA does appreciate that the FDA as well as the federal district court have gone on to acknowledge the distinct value and safety when it comes to the laboratory tests that are developed by hospitals and health systems for direct use in patient care. The point is that the return to enforcement discretion for laboratory-developed tests happens to rightly recognize that applying the device regulations to such kinds of tests is most likely to prompt many hospital laboratories, especially the small ones, to stop offering safe as well as effective tests upon which patients and, of course, their communities depend. This sort of action is sure to help to assure the patient access to innovative as well as targeted diagnostic tests while at the same time, reducing regulatory burden along with expenses for both hospitals and the federal government.
Apparently, the final rule is going to become effective after an official publication in the Federal Register on September 19.
