The Barrier is Gone: FDA Finalizes Order Opening the Door for Oral Fluid Drug Testing in Federal Programs

Coalition led by NDASA leadership delivers the regulatory change the industry has pursued for years.

Washington, DC October 06, 2026 –(PR.com)– The National Drug and Alcohol Screening Association (NDASA) today announced that 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.

“This marks the day that oral fluid testing can proceed to market,” said Scott Taillie, Chairman of NDASA. “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 outcome is the direct result of a coalition led by Scott Taillie, Chairman of NDASA; Jo McGuire, Executive Director of NDASA; James Greer, Chairman Emeritus of NDASA; R.H. Barry Sample, Ph.D., nationally recognized drug testing expert; and government affairs strategist Tim Monahan. Together they built the regulatory argument, took it directly to HHS leadership, and engaged Congress, resulting in a formal letter to the HHS Secretary from six members of the House in April. The FDA proposed the change on May 1, and finalized it today without modification after a public comment period that drew roughly 70 responses, most of them in support.

“This is what happens when an industry speaks with one voice,” said Jo McGuire, Executive Director of NDASA. “Our members, our partners, and this coalition showed up, made the case, and stayed with it. Employers and the traveling public will be safer because of it. NDASA will now turn its full attention to working with SAMHSA and DOT so that implementation moves as quickly as the science allows.”

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.

The full order is available at https://www.federalregister.gov/d/2026-20448

Contact Information:
National Drug and Alcohol Screening Association
Jo McGuire
888-316-3272
Contact via Email
www.ndasa.com
info@ndasa.com

Read the full story here: https://www.pr.com/press-release/981116

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