The IVDs are prescription devices and indicated to aid in the diagnosis of diseases caused by the Bacillus species, including anthrax. They are intended for the detection and differentiation of the bacteria, such as Bacillus anthracis, and had been unclassified devices prior to FDA’s final classification regulation.
The final rule comes as the awareness of the anthrax bioterrorism threat has been raised since the 11 September 2001 events in the US and the anthrax letters. "Anthrax is a bioterrorism threat because the spores are resistant to destruction and can be spread by release in the air,” FDA Commissioner Scott Gottlieb said on Friday. “Exposure to anthrax can and has caused serious injury or death.”
Gottlieb noted device manufacturers have inquired about how the agency reviews tests that can detect Bacillus anthracis, citing the important role such devices play in a public health response to an anthrax attack. The final rule is the culmination of FDA’s “effort to provide a clear and predictable review pathway for these specific test developers” as it helps “understand the requirements, including testing criteria and how to address potential safety risks for lab workers using the devices,” Gottlieb added.
The decision to finalize the class II regulation resulted from recommendations made by the Microbiology Devices Advisory Panel in 2002. Rather than that of de novo classification requests, most unclassified devices have been classified under device classification panel procedures. The procedures involved a 2016 comment period, though the proposed rule for the IVDs did not receive any relevant comments.
The final rule will come into effect 30 days from its publication in the Federal Register. FDA clarified that manufacturers are not required to submit a 510(k) for IVDs legally marketed prior to the publication of the final rule. For such devices, the agency does not intend to enforce compliance with the special controls in sections VI, VII and IX of a new FDA guideline issued in conjunction with the final rule. Yet the final rule established a one-year grace period for such devices to comply with the labeling special controls set forth in section VIII of the guideline, after which FDA intends to consider taking enforcement actions.
The implementation strategy differs, however, for manufacturers required to submit a new 510(k) for devices undergoing significant changes or modifications. In addition to those that have not been legally marketed prior to the final rule, modified devices must comply with the new set of special controls.
The new class II special controls guideline on IVD devices for Bacillus species detection is partly based on the feedback from the device classification panel. Special controls identified in the guideline relate to device description requirements, performance studies and labeling, among other specific IVD requirements.
The requirements that will eventually apply to all devices, including those that are currently legally marketed, fall under labeling. Labeling special controls in the new guideline address IVD intended use, directions for use, precautions, performance characteristics as well as interpretation and reporting of assay results.
The final rule also restricts the use and distribution of IVDs for Bacillus species detection to laboratories that follow public health guidelines.
The class II assignment follows on the heels of the new Tri-Agency Task Force for Emergency Diagnostics’ launch to facility the rapid development and deployment of IVDs during public health emergencies.