Lawmakers Unveil FDA-Inspired Bill Regulating Diagnostic Tests

In a surprise move Thursday (Dec. 6), bipartisan duos of House and Senate lawmakers released draft legislation that lays out a framework for FDA to regulate in vitro clinical tests, such as test kits and laboratory developed tests (LDTs). At first glance, the draft legislation appears to closely resemble a legislative proposal put forward by FDA in August that drew initial criticism from industry for its sweeping changes and unclear terminology. Lawmakers say that the Verifying Accurate, Leading-edge IVCT Development...