On April 1st, the FDA issued a final rule that classifies In Vitro Diagnostic Devices (IVDD) for Bacillus Species Detection as class II devices requiring premarket notification through the 510(k) review process. The purpose of this type of device is to detect and differentiate among Bacillus species for diagnosis in a clinical setting with particular reference to diagnosis of anthrax by detection of B. anthracis. The agency also issued a final guidance outlining the special controls required to mitigate health risks and provide a reasonable assurance of safety and effectiveness for these devices. There are three primary risks associated with this type of device:

1. False negative results – leading to delay of therapy and progression of disease;
2. False positive results – leading to unnecessary or ineffective treatment; and
3. Biosafety risks – to lab workers handling test specimens and control materials.

Each of these risks is mitigated through the control measures listed in the guidance. The fourth type of risk comes from the unique device being proposed. Sponsors must perform a risk assessment for their unique device and propose additional control measures to address these risks.

The control measures in the guidance include specific descriptive requirements, performance studies with the device in both laboratory and clinical settings, and labeling requirements. Additional requirements are included for devices that use nucleic acid amplification as part of the detection process.

Text Copyright © 2019 Katrina Rogers