The U.S. Food and Drug Administration (FDA) on Monday issued a final rule that restricts both the use and distribution of Bacillus bacteria detection devices, which are prescribed to preliminarily identify and diagnose cases of anthrax and other infectious diseases.
“The FDA plays a critical role in protecting our nation from bioterrorism threats such as anthrax,” said Dr. Scott Gottlieb, FDA commissioner. “Anthrax is a bioterrorism threat because the spores are resistant to destruction and can be spread by release in the air.”
Anthrax is caused by Bacillus anthracis, a disease that humans acquire directly from contact with infected herbivores or indirectly via their products, according to the National Center for Biotechnology Information (NCBI), which is part of the National Institutes of Health.
For instance, people might get anthrax from handling infected material, which the center said accounts for more than 95 percent of cases; from eating infected meat; and from inhaling spore-laden dust, the NCBI says.
“Exposure to anthrax can and has caused serious injury or death,” Dr. Gottlieb said.
The newly published final rule from the FDA, which is an agency within the U.S. Department of Health and Human Services, now classifies as moderate-risk the in vitro diagnostic device used to detect Bacillus species (spp.). The classification is listed in the FDA’s guideline, “Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection,” which restricts the device to prescription use only and curtails its distribution.
“FDA believes that the special controls established and imposed by this final rule and special controls guideline, together with the general controls, will provide a reasonable assurance of safety and effectiveness of the device,” according to the FDA’s final rule published in the April 1 Federal Register. “Further, FDA believes that the restrictions on use and distribution are required for the safe and effective use of the device.”
The decision to do so was based on recommendations from the Microbiology Devices Advisory Panel, as well as public comments filed in response to the FDA’s proposed rule and the agency’s experience with these devices, according to the final rule.
Gottlieb said the rule “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.”
The FDA’s distribution restriction on these products is limited to just those laboratories that follow public health guidelines addressing biosafety conditions, interpretation of test results, and coordination of findings with public health authorities, according to the final rule.
Such action will lessen the risks associated with handling Bacillus spp. specimens, which pose anthrax exposure risks, especially to lab workers who handle them, said Gottlieb.
The final rule also will ensure manufacturers continue providing consistent information on testing criteria and performance evaluations as they work to bring new Bacillus bacteria detection devices to market, according to the FDA.
“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 explained last week.
The devices previously were unclassified since they went into commercial distribution before medical device amendments to the Federal Food, Drug, and Cosmetic Act became law in 1976.
The FDA’s new final rule becomes effective on May 1.