FDA exempted 14 generic types of drug-of-abuse test system from premarket notification on October 6, effective the same day. The list runs from the amphetamine test system at 21 CFR 862.3100 to the tricyclic antidepressant drugs test system at 862.3910, taking in cocaine, methamphetamine, methadone, opiate and cannabinoid test systems along the way. Each exempt type gets a new product code, PUX through PVK.
The exemption is conditional. The test has to be intended for employment and insurance testing, and the labeling has to state it is intended solely for that use. The order newly covers devices intended for federal drug testing programs, which the previous limitation excluded. Oral fluid collection devices were left out, because FDA has not concluded that a 510(k) is unnecessary for them. The agency took roughly 70 comments on the May proposal, in a period that closed June 30, before finalizing.
Anyone selling into clinical use still files. The exemption follows the labeled intended use, and 21 CFR 862.9 pulls it back for a device intended for a use different from the generic type, or built on a different fundamental scientific technology. The regulatory savings are real for a workplace testing product and nonexistent for the same chemistry pointed at a clinical claim.