A VALID Argument: Proposed Legislation Would Reshape Regulation of Diagnostics
FDA Law Blog
JULY 8, 2021
Javitt — For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). At various points and in various ways, FDA has sought – mostly unsuccessfully – to regulate LDTs (see here ).
Let's personalize your content