FDA issues final rule classifying Bacillus species detection tests

April 1, 2019

The FDA issued a final rule classifying in vitro diagnostic devices for the detection of Bacillus bacteria into class II (special controls) and continuing to require a premarket notification (510(k)) for these devices. This final rule and the accompanying special controls guideline will help assure 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. These devices were previously unclassified preamendments 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 this final rule. The FDA does not intend to enforce compliance with the labeling special controls set forth in section VIII of the special controls guideline until one year from the date of publication for devices legally marketed before the publication of this final rule.

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