Dive Brief:

• The Food and Drug Administration has published final guidance on devices for determining the susceptibility of bacterial or fungal pathogens to different antimicrobial agents.
• In the guidance, the FDA explains how test developers can update the “breakpoints” that define susceptibility and resistance to antimicrobials without submitting a 510(k) filing for each change.
• The guidance focuses on predetermined change control plans, a mechanism the FDA sees as a way to streamline updates in areas ranging from artificial intelligence to cancer tests.

Dive Insight:

The FDA published guidance on antimicrobial susceptibility testing (AST) devices in 2009. Based on that document, the agency allowed companies to update breakpoint change protocols without submitting a new 510(k) filing. However, the guidance lacked procedures for updating the AST system device labeling when using a breakpoint change protocol.

The new guidance, which supersedes the 2009 document, is intended to address that gap. In the text, the FDA describes the use of predetermined change control plans to update device labels. Manufacturers propose a plan in an initial 510(k) submission to prespecify and seek clearance for breakpoint updates in advance. When a company needs to make a prespecified change, it can rely on the plan rather than make a new 510(k) application.

Different sections of the guidance cover how to establish and use a predetermined change control plan, and describe its content. The FDA also explained how to apply the approach to legacy AST devices that were cleared without a predetermined change control plan. 

The approach could address a historical problem with the AST label update process. As new information on the resistance of pathogens accrues, the FDA-cleared breakpoint recommendations may become out of date. However, the traditional regulatory process is not designed to facilitate small, frequent updates to diagnostics and medical devices. 

“There have been delays in updates of AST system device labeling — following the recommendations of standards development organizations that breakpoints be changed — until after the relevant antimicrobial drug labeling was revised to include the updated breakpoint,” the FDA wrote in the final guidance. 

The FDA finalized the guidance without releasing a draft version for consultation. The move straight to the final test reflects the agency’s determination “that prior public participation for this guidance is not feasible or appropriate.”