FDA Removes Regulatory Barrier to Oral Fluid Testing: What it Means for Safety-Sensitive Employers

On October 6, the Food and Drug Administration (FDA) issued a landmark final order removing the 510(k) premarket notification requirement for clinical toxicology test systems used in federal drug testing programs.

This news made an immediate impact for employers in safety-sensitive environments regulated by entities such as the Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC). For employers who had been hoping for progress while oral fluid testing remained tied up in administrative limbo, the final rulemaking brings exactly the change they sought.

Plain English: What “Removing the 510(k)” Means

Under standard FDA rules, device manufacturers must submit a “510(k)” clearance to prove a new testing system is equivalent to existing market products before selling it.

While the DOT and Department of Health and Human Services (HHS) previously authorized oral fluid testing, HHS requires at least two certified laboratories (one primary, one secondary) to process specimens. Laboratories couldn’t yet complete their certification applications because oral fluid test devices were stuck in the FDA’s clearance process.

The latest FDA order officially exempts federal oral fluid drug testing systems from premarket 510(k) clearance. In simpler terms, the FDA removed the red tape. Test device manufacturers can now supply laboratories immediately, clearing the final hurdle for labs to apply for certification through the National Laboratory Certification Program (NLCP). Once labs are certified, it’s time for federal oral fluid testing to begin.

Easier Days Ahead for Employers

For employers managing drug and alcohol compliance, oral fluid testing solves several key operational challenges:

• Eliminates “Shy Bladder” Delays: Collections are rapid, ending clinic wait times for employees unable to produce a urine sample.
• Reduces Off-Site Travel: Collections can take place directly at your facility or fleet yard, saving time and lost productivity.
• Deters Specimen Tampering: Standard oral fluid collections are directly observed, virtually eliminating adulteration, synthetic substitution, or dilution.
• Captures Recent Usage Rapidly: Oral fluid detects recent drug use faster than urine metabolites, creating a highly defensible tool for post-accident and reasonable suspicion testing.

Updating Your Workplace Policies

Even though the oral fluid testing green light appears imminent, employers cannot simply switch testing methods overnight. To maintain audit-ready compliance, organizations must update their written drug and alcohol policies proactively. It is also recommended that organizations have a standing order for those performing collections on their behalf that matches the organization’s policy.

Those policies should clearly authorize oral fluid alongside urine testing and establish clear protocols for when to use each method. But it’s not “one-size-fits-all.” For example, employers who wish to rely on third-party testing centers will need to decide how oral fluid testing fits into their programs and when.

In addition to policy, as with any new drug and alcohol testing method, organizations must:

• Work with their vendors to establish which labs to use
• Discuss who is collecting the oral fluid test
• Confirm the collector(s) have successfully gone through DOT collector training

So, while the operational benefits of oral fluid testing are numerous, organizations need to sufficiently prepare their people and their policies so that they reap those benefits while keeping workplaces safe.

Partner with ASAP

Navigating regulatory updates while maintaining flawless compliance across your workforce requires an experienced partner. At ASAP, we help DERs, HR leaders, and safety teams design compliant drug-free workplace policies and seamlessly manage the entire Return to Duty process, regardless of what testing methodology your organization uses.

Contact ASAP today to consult with our compliance experts and compose new drug testing policies for your workforce ahead of full lab certification for DOT drug testing. You can easily reach us at info@go2asap.com or by calling 888-792-2727 ext. 607.