'Reined-In' US Diagnostics Legislation Adds Pre-Certification, Other Updates

12 Dec 2018

• By Sue Darcey

A revised bill is circulating in both the US House and Senate to revamp FDA regulation of diagnostics. It would allow the agency to leverage a pre-certification process to validate test developers and includes other updates that are likely to appeal to the lab sector. But user fees and other elements could still be contentious.

Medic staff at work in the laboratory. Background

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...