Big Step Forward For Oral Fluid Testing

In October 2026 the Food and Drug Administration has issued its final order removing the 510(k) premarket notification requirement for clinical toxicology test systems intended for use in Federal drug testing programs. The order took effect immediately upon publication in the Federal Register.

  "For years the science was proven, and the industry was ready, but a regulatory carve-out stood in the way. Today's order eliminates the largest barrier to laboratory and industry adoption. Laboratories can now invest with confidence, manufacturers can bring product forward, and the safety-sensitive workforce this country depends on can finally be protected with modern tools."

The final order applies to 14 categories of drug test systems, including those for amphetamines, cocaine, cannabinoids, and opiates, with fentanyl included. Test systems remain subject to FDA quality, labeling, and reporting requirements, as well as SAMHSA's mandatory guidelines.

Now 2 laboratories can be identified to allow for split samples. This is a big step forward.