Four More Guidance Documents Released: Antimicrobial Devices, Closed-Loop Control Technology, De Novo Submissions, Devices For Graft Versus Host Diseases

The US FDA recently published four guidance documents, two final — one concerning antimicrobial susceptibility test system devices and another related to devices with physiologic closed-loop control technology. The agency’s two draft documents pertain to electronic submissions for de novo requests and graft-versus-host diseases.

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The US Food and Drug Administration issued four guidance documents on 29 September, the first a final guidance “Antimicrobial Susceptibility Test System Devices—Updating Breakpoints in Device Labeling,” which the agency said is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretative criteria (STIC) — or breakpoints — and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices.

Timely adoption of updated breakpoints in AST system devices is important, according to the FDA, because it helps to...