In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. § 809.3. The Final Rule completely changed the regulatory status of Laboratory Developed Tests (“LDTs”) by adding the following additional language: “including when the manufacturer of these products... READ MORE
From Discretion to Regulation: What FDA’s Final Rule Means for Laboratory Developed Tests
Posted on June 5, 2024 in Health Law News
Published by: Hall Render
