FDA issued a final rule classifying in vitro diagnostic devices for the detection of Bacillus anthracis (the bacteria that causes anthrax) into class II (moderate-risk) with special controls, which means the agency will continue to require a 510(k) premarket notification for these devices.
“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," said FDA Commissioner Scott Gottlieb, MD, who is expected to resign soon.
Gottlieb said that access to safe and effective devices that can detect Bacillus anthracis in the body is an important part of the public health response to an anthrax-related attack. He said the rule issued on Friday finalizes the agency's effort to provide a clear and predictable pathway for these specific test developers.
"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," Gottlieb said.
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, FDA said it also is restricting 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 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 this 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.