The US Food and Drug Administration (FDA) has updated its final guidance on antimicrobial susceptibility test (AST) system device labeling based on breakpoint updates through the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria (STIC) website.
The final guidance, released on 28 September 2023, contains recommendations and expectations for the content of marketing submissions for predetermined change control plans (PCCPs) that reference AST system device labeling updates, but does not provide recommendations for other AST system device planned modifications, such as those not related to breakpoint updates. The guidance provides a “least burdensome” approach for manufacturers to update their AST system device labeling, according to the agency…
