The Food and Drug Administration (FDA) on Wednesday finalized a rule removing a long-standing regulatory hurdle that stalled oral fluid drug testing for truck drivers and other safety-sensitive industries.
The new rule exempts regulated drug testing devices from the 510(k) premarket notification requirement, which served as the primary obstacle for laboratories seeking certification to perform oral fluid testing, effectively delaying the method despite its approval for regulated use more than three years ago.
"A modern drug testing program is essential to keeping impaired drivers off the road and protecting the motoring public," said Henry Hanscom, American Trucking Associations chief advocacy and public affairs officer. "After years of ATA advocacy, FDA has finally removed a major regulatory roadblock that prevented oral fluid testing from moving forward."
An FDA 510(k) premarket notification is a submission made to the FDA that proves a new medical device is as safe and effective as a legally marketed device already on the market. In its final order, FDA is expanding the 510(k) exemptions for regulated toxicology tests to include devices intended for federal drug testing programs.
For more than a decade, the trucking industry has warned that an overreliance on urine testing created dangerous gaps, including widespread test tampering. According to an analysis of Quest Diagnostics data, substituted and invalid urine specimens increased by 370% and 36%, respectively, between 2022 and 2023 among federally regulated, safety-sensitive workers.
Supporters say oral fluid and hair testing methods are less susceptible to substitution because they are directly observed. Hair testing also offers a longer detection window to identify past drug use.
The FDA initiated its rulemaking process earlier this year after six members of Congress in April sent a letter at ATA’s request to the U.S. Department of Health and Human Services. ATA submitted formal comments on the proposed rule in June.
The final rule is the result of a multiyear push by the ATA, the National Drug & Alcohol Screening Association, and allied groups to eliminate bureaucratic barriers to modernizing federal drug testing protocols.
