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  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

In Vitro Diagnostic Devices for Bacillus spp. Detection - Class II Special Controls Guideline for Industry and Food and Drug Administration Staff

Read the Special Controls Document

Issue Date: 04/01/2019

Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health

This special controls guideline was developed to establish special controls for in vitro diagnostic devices for Bacillus species (spp.) detection.