FDA has issued a final rule classifying in vitro diagnostic devices for the detection of Bacillus bacteria into Class II (special controls) while continuing to require a premarket notification (510(k)) for these devices.
The final rule and the accompanying special controls guidelines will help to ensure that manufacturers continue to use appropriate practices for these devices and provide consistent information on testing criteria and performance evaluations for bringing safe and effective new Bacillus bacteria detection devices to market.
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. Such devices were previously unclassified preamendment devices that were legally marketed prior to May 28, 1976, when the medical device amendments to the Federal Food, Drug, and Cosmetic Act were signed into law.
Manufacturers do not need to submit a 510(k) for devices legally marketed before the publication of the final rule. For such devices, FDA does not intend to enforce compliance with the special controls for labeling set forth in the special controls guideline until 1 year from the date of publication.
For further information, visit FDA.
Featured image: Under a magnification of 1150x, this Gram-stained photomicrograph depicts numerous Gram-positive, rod-shaped, Bacillus anthracis bacteria, which are arranged in long filamentous strands. CDC Public Health Library/ID 20496.
