Regulatory Strategy

Department of Transportation

Different from clinical diagnostic tools, our hardware classifies as a quantitative measurement tool, abiding to different standards compared to the FDA. The device would have to go through standards of California’s Department of Transportation similar to a breathalyzer. We will work with municipality-approved business partners to go through proper device verification within 2 years. Proper bench testing and risk assessment will be performed by conducting a Device and User Failure Mode Effects and Criticality Analysis (FMECA). We expect to minimize the risk to the end user through this process.

FDA 510(k) Clearance

Regarding the saliva assay, the FDA considers most drug of abuse tests as a Class II device and require 510(k) clearance prior to marketing. The saliva assay with the imaging hardware would need to prove: analytical validity, clinical validity, and proper labeling (according to Code of Federal Regulations, Title 21, Part 809, Section 10). This regulation will ensure Good Manufacturing and Documentation Practices to properly regulate the saliva assay. However, this is debated; the FDA does not actively regulate (via enforcement discretion) devices labeled for forensic and law enforcement use.  Furthermore, it is possible to approve the device as a Class I device. As described, the device is simple as inserting the saliva assay sample and processing through the image analysis software. This would be proved by showing device equivalence and registering into the FDA Manufacturing Registration and Device Listing.