NILA and American Association of Bioanalysts (AAB) Respond to FDA's Release of Final Rule on LDTs

Update May 6, 2024: The final rule was officially published in the May 6, 2024, Federal Register

The FDA released today its final rule on oversight of Laboratory Developed Tests (LDTs).

Click here for NILA/AAB's press release about the final rule, and click here for the FDA's statement about the rule.

The rule runs 528 pages, will be printed in the Federal Register on May 6, 2024, and becomes effective 60 days after publication in the Federal Register (on July 5, 2024).

Additional information will be available soon.