FDA extends 510(k) exemption to federal-program use for 14 drug test types

The U.S. Food and Drug Administration (FDA) published a final order in the Federal Register on October 6, 2026, effective that day. It changes how certain drug test systems are reviewed before sale in the United States.

Until now, certain class II clinical toxicology test systems were exempt from premarket notification, known as 510(k), unless they were meant for federal drug testing programs. The order lifts that exception for 14 generic device types, including systems for cocaine, opiates and cannabinoids. FDA says a 510(k) review is not needed for these devices to be safe and effective. The exemption applies only to test systems intended solely for employment and insurance testing, within FDA’s limits, and FDA said oral fluid collection devices were not included. FDA says registration, listing, quality system and labeling requirements still apply.

FDA says it regulates the devices used in federal programs but does not oversee the programs, which its footnote says include those run by the Department of Transportation. Of about 70 commenters, it said most supported the change.

Transport Topics reported on October 8 that the American Trucking Associations (ATA) pushed for the change and that industry groups said the old requirement was holding up federal certification of laboratories for oral fluid and hair testing. Those are the outlet’s attributions, not FDA’s findings.