This draft special controls guideline was developed to establish special controls for in vitro diagnostic devices for Bacillus species (spp.) detection.
This guideline identifies measures that FDA believes would mitigate the risks to health associated with these devices and provide a reasonable assurance of safety and effectiveness. Following the effective date of a final rule classifying the device, manufacturers of in vitro diagnostic devices for Bacillus spp. detection will need either to (1) comply with the particular mitigation measures set forth in the special controls guideline or (2) use alternative mitigation measures, but demonstrate to the Agency’s satisfaction that those alternative measures identified by the firm will provide at least an equivalent assurance of safety and effectiveness.