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.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
