FDA Unveils Guidances Aimed At Streamlining In Vitro Diagnostics Reviews

FDA released two final and one draft guidance Thursday (April 12) aimed at streamlining the process by which in-vitro diagnostic manufacturers can come to market, and the newly unveiled policies may allow certain Next Generation Sequencing tests to be down classified from Class III and be exempted from premarket review. The two final guidances, which outline how a genetic variant database can be used to support clinical validity of an IVD and the process for demonstrating the analytical performance of...