View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
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:
|
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: Karen Fikes Regulatory Counsel 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: karen.fikes@fda.hhs.gov |