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.