Frequently Asked Question
What Did FDA's October 2026 Order Change for Drug Test Devices?
Effective October 6, 2026, FDA exempted certain class II drug test systems intended for federal drug testing programs from 510(k) premarket notification, as long as they are intended for employment and insurance testing and stay within the limits in 21 CFR 862.9 (Federal Register 2026-20448). The exemption was immediately in effect on publication.
What changed. FDA removed the earlier exception that kept devices intended for federal drug testing programs out of the 510(k) exemptions for several clinical toxicology test systems. It amended the classification language in 21 CFR 862.3100, 862.3150, 862.3170, 862.3250, 862.3270, 862.3580, 862.3610, 862.3620, 862.3630, 862.3640, 862.3650, 862.3700, 862.3870 and 862.3910 (Federal Register 2026-20448).
Rulemaking history. FDA announced its intent in a May 2026 notice, took comments through June 30, 2026, and received comments from about 70 commenters (Federal Register 2026-20448).
Fentanyl tests. Fentanyl test systems generally fall under the opiate test system regulation in 21 CFR 862.3650, so fentanyl tests intended for federal drug testing programs are included. Devices previously under product code DJG now fall under product code PVH if they stay within the limits, including use solely in employment or insurance testing (Federal Register 2026-20448).
Other rules still apply. Exempt devices remain subject to establishment registration, device listing, labeling, quality management system and medical device reporting requirements (Federal Register 2026-20448).
Who oversees federal programs. FDA does not run federal drug testing programs. SAMHSA's Division of Workplace Programs oversees federal drug-free workplace programs and the National Laboratory Certification Program, which certifies laboratories for federal agencies and federally regulated industries (Federal Register 2026-20448). The FAQ on certified laboratories for drug testing covers that system, and the FAQ on what fentanyl is covers the drug.
Classification. The FAQ on FDA drug test device classification lists the device types by drug.
We are not a law firm. The information on this website is for informational purposes only and may not be up to date. Always consult a licensed attorney for personalized legal advice.
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