Notable FDA HHS

FDA Classifies Bacillus spp. Secreted-Protein IVD as Class II with Special Controls

The classification establishes a defined regulatory pathway for simple in vitro diagnostic devices detecting Bacillus species secreted proteins in human clinical samples, potentially accelerating market access. The FDA has issued a final order classifying the simple in vitro diagnostic (IVD)...

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Health and Human Services Department, Food and Drug Administration · 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 · Jun 22