For more than three years, oral fluid drug testing has been authorized under DOT rules but stuck on the sidelines. On October 6, 2026, that changed in a meaningful way.
The FDA published a 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 and covers 14 categories of drug test systems, including amphetamines, cocaine, cannabinoids, opiates and fentanyl.
Why this matters
DOT added oral fluid to 49 CFR Part 40 in a final rule published in May 2023. Before any employer can use it, though, HHS has to certify laboratories to test oral fluid specimens. Labs could not realistically complete that process while the test systems they needed were held up by a separate FDA clearance requirement. With that barrier gone, laboratories can move forward with HHS certification.
The order matters for hair testing too. Hair faced the same 510(k) issue and would have hit the same wall once HHS finalizes its hair testing guidelines.
What it does not do
The FDA order does not make DOT oral fluid testing available today. DOT still requires at least two HHS certified oral fluid laboratories before an employer can use the method: one to test the primary specimen and a second to test the split specimen if the employee requests it. As of this writing, no laboratory has been certified for oral fluid, so urine remains the only specimen type for DOT drug tests.
What to do now
The industry has heard "soon" before, but this time the largest obstacle has been removed. That makes now the right time to prepare.
• Collectors: get qualified on oral fluid procedures before demand spikes.
• Employers and DERs: review your testing policy and decide whether and when you plan to use oral fluid.
• TPAs and collection sites: plan capacity, devices and staffing so you are ready when the second lab is certified.
• Everyone: bookmark DOT's list of HHS certified oral fluid laboratories at transportation.gov/odapc, which DOT will update as labs are certified.
How Stratellis Training can help
Our DOT Oral Fluid Collector Training is built to the federal requirements and can be completed online at your own pace. For organizations preparing a team, we offer group training and live mock collections, in person or remote. Explore our courses or reach us at sales@stratellistraining.com.