The FDA has created a new category of infection diagnostic devices designed to detect microorganism nucleic acids and antimicrobial resistance markers.
The agency classified the devices as Class II through the de novo pathway and established special controls for the category, according to a May 12 Federal Register notice. The devices are intended to analyze human clinical specimens from patients with suspected infections and identify microorganisms and resistance markers.
The FDA said the classification is intended to provide “reasonable assurance of safety and effectiveness” while reducing regulatory burdens and improving access to innovative diagnostic technologies.
The classification stemmed from a de novo request submitted Oct. 27, 2020, by BioFire Diagnostics for its BioFire Joint Infection Panel. FDA issued the classification order April 29, 2022, and codified the device type, effective May 12, 2026.
According to the notice, the devices are intended to support diagnosis alongside clinical signs, symptoms and laboratory findings, but are not meant to replace traditional culture and susceptibility testing.
