Bipartisan bill would revamp diagnostics regulation

Champions of legislation in Congress to overhaul diagnostics legislation released a draft bill Thursday that scraps many features of a draft bill released last year and incorporates a different approach proposed by FDA.

If it is enacted, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act would create a completely new system for regulating diagnostics, and would resolve controversy that has raged for over a decade about FDA’s authority to regulate laboratory developed tests (LDTs). ...