Federal Register #FDA-2026-N-6239

FDA Classifies Bacillus Diagnostic and Endoscopic Measuring Devices as Class II with Special Controls

This opportunity summary covers the FDA's classification of two medical devices into Class II with special controls: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Office: Center for Devices and Radiological Health - Devices Classified: - Simple in vitro diagnostic device for detection of secreted proteins from Bacillus species (spp.) in human clinical samples - Part number: 866.3046 - Intended for prescription use to aid in diagnosing anthrax and other Bacillus-related diseases - Subject to special controls: labeling requirements, biosafety guidelines, and performance validation - Endoscopic light-projecting measuring device - Classified as Class II with special controls to ensure safety and effectiveness - OEMs and Vendors: - No specific manufacturers or vendors are named in the notice - Products/Services Requested: - No procurement, purchase quantities, or specific product requests are included - Notable Requirements: - Devices must comply with special controls, including detailed labeling, instructions to minimize user exposure and contamination, and clear statements about the presumptive nature of test results - Classification is intended to reduce regulatory burdens and improve patient access to innovative devices - Additional Notes: - This is a regulatory classification notice, not a procurement or award announcement

Description

The Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples into class II with special controls. This classification aims to ensure safety and effectiveness of the device and improve patient access by reducing regulatory burdens. The device is subject to premarket notification requirements under section 510(k) of the FD&C Act. The classification was applicable on February 3, 2023, and the order is effective from June 22, 2026.

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