FDA Removes Regulatory Barrier to Oral Fluid Drug Testing for Truck Drivers

The U.S. Food and Drug Administration (FDA) removed a federal regulatory requirement on October 6 that could help speed up the introduction of saliva-based drug testing for commercial truck drivers.

Under the final order, certain drug testing systems used in federal programs are now exempt from the FDA's premarket notification process, known as 510(k). The change covers qualifying clinical toxicology tests, including systems that detect cannabinoids, opiates and other controlled substances.

The decision removes one regulatory obstacle for testing equipment manufacturers, but it does not immediately authorize trucking companies to begin DOT-regulated saliva testing. The Department of Transportation still requires at least two laboratories certified by the Department of Health and Human Services (HHS) before employers can use oral fluid testing.

DOT's published laboratory information continues to show no HHS-certified oral fluid testing laboratories. Until the required certifications are in place, existing DOT drug testing procedures remain unchanged for CDL drivers.