Regulatory Counsel

0910-AH98 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection

The final rule will classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) FDA is establishing special controls in a special controls guideline that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the devices. Bacillus spp. is used to detect and differentiate among Bacillus spp. and presumptively identify Bacillus anthracis (B. anthracis) and other Bacillus spp. from cultured isolates or clinical specimens, as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Final Rule Stage No No Other 21 CFR 866 21 U.S.C. 351 21 U.S.C. 360 21 U.S.C. 360c 21 U.S.C. 360e 21 U.S.C. 360j 21 U.S.C. 371 No Final Rule 03/00/2019 No No None No No No No Karen Fikes Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 karen.fikes@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301, Silver Spring MD 20993