Devices

AST Device Labeling Breakpoints Guidance

FDA has published a guidance, Antimicrobial Susceptibility Test (AST) System Devices — Updating Breakpoints in Device Labeling, with information about updating susceptibility test interpretive 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 STIC Web site. The document says it is expected to facilitate the timely adoption of updated breakpoints in AST system devices, which helps to ensure device safety and effectiveness.

The guidance supersedes two sections of a 2009 guidance. It describes approaches for AST system device sponsors to update their STIC in device labeling via predetermined change control plans, and also describes an enforcement policy about applying such updates to AST system devices that were cleared without breakpoint change protocols.

FDA says it is implementing the guidance without public comment because the agency has determined that prior public participation for the guidance was not feasible or appropriate. It says it has determined that the document presents a less burdensome policy that is consistent with public health and the urgent public health need for sponsors to update breakpoints for legacy AST system devices. Although it is being implemented immediately, the guidance is still subject to comment following FDA’s good guidance practices.

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