FDA finalizes requirements for anthrax diagnostic devices

2019-04-09 |

The FDA has classified in vitro diagnostic devices for the detection of Bacillus bacteria into class II (moderate-risk) with special controls, which means the agency will continue to require a 510(k) premarket notification for these devices. Bacillus bacteria detection devices are prescription devices that provide a preliminary identification of Bacillus anthracis and other Bacillus species to help diagnose cases of anthrax and other diseases caused by Bacillus bacteria. These devices were previously unclassified.