The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls), in accordance with the recommendations of the Microbiology Devices Advisory Panel (the Panel). FDA is also issuing a draft special controls guideline that the Agency believes is necessary to provide a reasonable assurance of the safety and effectiveness of the device. In addition, when final, the rule will establish restrictions on use and distribution of this device.
Regulatory Impact Analysis
Federal Register: 80 FR 71756, November 17, 2015