Law & safety

FDA clears key hurdle for DOT oral fluid drug testing — but labs still need HHS certification

An Oct. 6 FDA order exempts clinical toxicology test systems used in federal drug testing programs from premarket notification — a major step toward oral fluid as a urine alternative, though DOT employers still can't use it yet.

By CDLWire · Published October 7, 2026

Summarized from The Trucker.

A medical professional in gloves collecting an oral fluid swab sample at a drug testing site

A major roadblock preventing motor carriers from using oral fluid for federally mandated drug testing has been removed, according to The Trucker on Oct. 7. The U.S. Food and Drug Administration finalized an order on Oct. 6 exempting certain clinical toxicology test systems used in federal drug testing programs from the agency's 510(k) premarket notification requirements — effective immediately.

The change does not mean trucking companies can start using oral fluid for Department of Transportation drug tests yet. DOT regulations require at least two laboratories certified by the Department of Health and Human Services to conduct oral fluid testing before employers can use the method — one for the primary specimen, another for the split specimen. The FDA action removes an obstacle to labs obtaining that certification: the order covers 14 categories of clinical toxicology test systems, including tests for amphetamines, cocaine and its metabolites, methamphetamine, cannabinoids, and opiates.

DOT authorized oral fluid as an alternative to urine testing in 2023, but implementation stalled because the laboratory infrastructure was never put in place. National Drug and Alcohol Screening Association chairman Scott Taillie said the order lets laboratories move forward with investments and manufacturers bring testing products to market, and the association will now focus on working with SAMHSA and DOT on implementation. Urine remains the only testing method available to DOT-regulated trucking employers for now — the next milestone to watch is HHS certification of the needed laboratories.