VALID Act Reintroduced With Bipartisan Support

A bipartisan group of U.S. lawmakers has reintroduced proposed legislation to “modernize the review process for diagnostic testing” and clarify the regulatory authority between the FDA and the Centers for Medicare and Medicaid Services (CMS).

Last year, Congress considered the VALID (Verifying Accurate, Leading-edge IVCT Development) Act as part of an omnibus spending package but ended up dropping the proposed provisions.

Co-sponsored by Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.), the proposed bill — which has the FDA’s support —would overhaul the agency’s oversight of in vitro diagnostics, and would create a new category.

CMS currently regulates laboratory-developed tests (LDTs), and the FDA regulates in vitro diagnostic (IVD) tests. If passed, the VALID Act would take IVD tests out of the medical device definition and create a new category of in vitro clinical tests (IVCTs) that includes LDTs and IVDs, which the FDA would regulate.

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