USA – FDA Fleshes Out Guidance on Susceptibility Breakpoints for Antimicrobial Drugs, Devices

The US Food and Drug Administration (FDA) issued final guidance Thursday on the coordinated development of antimicrobial drugs and susceptibility assays, with additional clarifications.

The finalization follows concerns raised by AdvaMed and BIO with the 2016 draft guidance’s lack of language to address the issue of antimicrobial susceptibility breakpoints among drug and medical device sponsors. The issue relates to leveraging the use of ka breakpoint as a vehicle for a device manufacturer to coordinate the development of an antimicrobial susceptibility test (AST) device early in the drug review and approval process with the manufacturer of the corresponding antimicrobial.

The new clarifications on breakpoints in the final version of FDA’s guidance coincide with its goal, which is largely centered on encouraging earlier interactions in development processes with an enriched understanding of AST devices’ corresponding antimicrobials. The agency’s 11-page guidance document is specifically dedicated to encouraging coordinated development processes that involve drug and devices manufacturers, as well as FDA’s Center for Devices and Radiological Health (CDRH) and its Center for Drug Evaluation and Research (CDER) upon request…