2023-21407: Antimicrobial Susceptibility Test System Devices-Updating Breakpoints in Device Labeling; Guidance for Industry; Availability
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The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry and FDA staff entitled "Antimicrobial Susceptibility Test (AST) System Devices--Updating Breakpoints in Device Labeling." This guidance is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretative criteria (STIC)/breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint changes posted on the FDA-Recognized Antimicrobial Susceptibility Test Interpretative Criteria website (STIC website). This guidance is expected to facilitate the timely adoption of updated breakpoints in AST system devices, which helps to ensure device safety and effectiveness.
The agency’s own summary, as published.
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