Regulatory hurdles for updating breakpoints for antimicrobial susceptibility test devices: What to know

The unique regulatory environment for the clearance and use of antimicrobial susceptibility test (AST) systems is complex in the U.S. While members of the medical microbiology community recognize the importance of updating breakpoints for clinical and public health, there is a knowledge gap regarding the regulatory requirements for breakpoint updates and how these requirements impact the medical laboratory's update processes.