Clinical laboratories and IVD-kit manufacturers could be pre-certified by US FDA to help bypass review and approval of their diagnostics under a draft bill floating in Congress, the "Verifying Accurate Leading-edge IVCT Development" (VALID) Act.
Provisions addressing pre-certification, along with a section allowing third-party review of certain test categories, are among several updates to the legislation compared to an earlier draft. Reps. Diana DeGette, D-Colo.,...
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