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HHS/FDA RIN: 0910-AH98 Publication ID: Fall 2018 
Title: Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection 
Abstract:

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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 866   
Legal Authority: 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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  05/18/2011  76 FR 28689   
NPRM Comment Period End  08/15/2011 
Reproposed NPRM  11/17/2015  80 FR 71756   
Reproposed NPRM Comment Period End  02/16/2016 
Final Rule  03/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Myrna Hanna
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301,
Silver Spring, MD 20993
Phone:240 402-7911
Email: myrna.hanna@fda.hhs.gov