Data / Federal rules / 2026-12443

Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples

The Food and Drug Administration published this final rule in the Federal Register on June 22, 2026. It took effect on June 22, 2026.

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What the agency says

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 (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Key facts

Document number: 2026-12443
Type: Final rule
Action: Final amendment; final order
Agency: Health and Human Services Department; Food and Drug Administration
Published: June 22, 2026
Takes effect: June 22, 2026
Dates: This order is effective June 22, 2026. The classification was applicable on February 3, 2023.
Docket: Docket No. FDA-2026-N-6239
Code of Federal Regulations: 21 CFR 866
Topics: Biologics; Laboratories; Medical devices
Pages: 5

The document on federalregister.gov PDF

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Everything from the Food and Drug Administration · Rules on biologics · Rules on laboratories · Rules on medical devices · Published in June 2026

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.