The US Food and Drug Administration issued four guidance documents on 29 September, the first a final guidance “Antimicrobial Susceptibility Test System Devices—Updating Breakpoints in Device Labeling,” which the agency said is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretative criteria (STIC) — or breakpoints — and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices.
Timely adoption of updated breakpoints in AST system devices is important, according to the FDA, because it helps to ensure device safety and effectiveness.
