March 29, 2019
“The FDA plays a critical role in protecting our nation from bioterrorism threats such as anthrax. Anthrax is a bioterrorism threat because the spores are resistant to destruction and can be spread by release in the air. Exposure to anthrax can and has caused serious injury or death. Access to safe and effective devices that can detect Bacillus anthracis—the bacteria that causes anthrax—in the body is an important part of the public health response to an attack involving anthrax. This is why device manufacturers have sought our advice on how the FDA reviews tests that detect the presence of Bacillus bacteria,” said FDA Commissioner Scott Gottlieb, M.D. “The rule issued today finalizes our effort to provide a clear and predictable review pathway for these specific test developers, which is a critical part of our commitment to fostering the development of innovative, safe and effective products to protect public health. This final rule helps manufacturers who market these products understand the requirements, including testing criteria and how to address potential safety risks for lab workers using the devices, to ensure availability of safe and effective diagnostic tests in the face of bioterrorism threats.”
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 the risk of exposure to anthrax, especially the risks that the quality control organisms and specimens associated with these devices could pose to lab workers, the FDA is also finalizing a restriction on distribution of these products to laboratories that follow public health guidelines to address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities, to reduce the risks associated with handling these specimens.
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, known as “preamendment devices,” since they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act were signed into law. Because of this, prior to today’s final rule there had not been a final agency determination about the testing criteria required, or the regulatory pathway to use for this type of device.
The final rule will become effective 30 days after its publication in the Federal Register.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.