FDA In Brief > FDA finalizes requirements to help foster access to safe and effective tests to detect anthrax-causing bacteria

FDA In Brief > FDA finalizes requirements to help foster access to safe and effective tests to detect anthrax-causing bacteria

FDA finalizes requirements to help foster access to safe and effective tests to detect anthrax-causing bacteria

Today, the U.S. Food and Drug Administration issued a final rule classifying 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 premarket notification (510(k)) for these devices. This rule will help ensure manufacturers continue to provide consistent information on testing criteria and performance evaluations for bringing safe and effective new Bacillus bacteria detection devices to market. Because of ...