Federal Register #2026-09335

FDA Classifies Orthopedic Infection Nucleic Acid Detection Device as Class II

This notice announces the FDA's regulatory classification of a device for detecting microorganism nucleic acids and resistance markers in orthopedic infections: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - BioFire Diagnostics, LLC (device sponsor for BioFire Joint Infection Panel) - Products/Services: - Qualitative in vitro diagnostic devices for detecting and identifying microorganism nucleic acids and antimicrobial resistance markers in human clinical specimens from patients with suspected orthopedic infection - No procurement or solicitation for products or services is included in this notice - Unique/Notable Requirements: - Devices are classified as class II (special controls) under 21 CFR Part 866 - Special controls address specimen collection, labeling, and design verification/validation - The BioFire Joint Infection (JI) Panel was reviewed under the De Novo classification process - This is a regulatory classification action, not a procurement opportunity

Description

The Food and Drug Administration (FDA) is classifying a device intended to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection into class II (special controls). This qualitative in vitro device aids in diagnosing orthopedic infections when used alongside other clinical signs, symptoms, and laboratory findings, but does not replace traditional culture and susceptibility testing methods. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices. The order is effective May 12, 2026, and includes special controls related to specimen collection, labeling, and design verification and validation.

View original listing