NEW YORK (360Dx) – The US Food and Drug Administration today issued a final rule classifying in vitro diagnostic devices for the detection of Bacillus bacteria into class II (special controls) and stated that the devices continue to require a premarket notification, or 510(k), clearance.
Bacillus bacteria detection devices provide a preliminary identification of Bacillus anthracis and other Bacillus species to help diagnose cases of anthrax and other diseases caused by Bacillus bacteria.
This final rule and the accompanying special controls guideline are designed to ensure that manufacturers continue to use appropriate practices for the devices, the FDA said.
Further, the rule and guideline are designed to provide consistent information on testing criteria and performance evaluations for bringing safe and effective new Bacillus bacteria detection devices to market, the agency added.
The class assigned by the FDA determines, among other things, the type of premarketing submission required for clearance to market devices. Class II devices are considered higher risk than class I devices, and makers must provide information that shows the products are safe and effective.
The FDA said that manufacturers do not need to submit a 510(k) application for clearance of devices legally marketed before the publication of the final rule. The rule takes effect 30 days after its date of publication in the Federal Register.