Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection
Information
Type
Rule
Regulated products
IVDMD
Published
April 1, 2019
Last updated
April 1, 2019
Description
Document number 2019-06026. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. FDA is also establishing special controls in a special controls guideline in addition to restricting use and distribution of the devices. An in vitro diagnostic device for Bacillus spp. detection is a prescription device used to detect and differentiate among Bacillus spp. and presumptively identify 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)