Clsi And Fda Breakpoints 2024. Since the fda recognizes the clsi breakpoints, ast device manufacturers can submit data demonstrating the performance of, and seek clearance for, those breakpoints on. The cures act clarifies fda’s authority to identify and efficiently update stic, including through fda recognition of standards established by sdos.

Aeruginosa led clsi to an update of the aminoglycoside. Read clsi’s new perspective piece on the fda’s ldt final ruling to learn about how we’ll be.