If FDA does not need to review your device before you sell it, how much of a quality system do you need? FDA gave a clear answer on October 6, 2026, when it removed the 510(k) requirement for 14 types of drug-screening tests: the same quality system as before.
The final order covers class II toxicology test systems for drugs including amphetamines, cocaine, opiates (which include fentanyl) and cannabinoids. These tests no longer need a 510(k) if two conditions are met. The test must be intended for employment and insurance testing, and its labeling must say it is intended solely for that use. The order took effect the day it was published.
FDA did not extend the exemption to oral fluid collection devices or PCP tests. The full list of device types and product codes is in the order, linked under Sources.
FDA was explicit: exempt devices remain subject to registration and listing, labeling, the Quality Management System Regulation (21 CFR 820) and medical device reporting. For a manufacturer of an exempt class II test, that means three things still apply:
A documented QMS that meets ISO 13485:2016, which the QMSR incorporates by reference.
☐ Confirm the classification regulation and product code for each device.
☐ Confirm the labeling states the test is intended solely for employment and insurance testing.
☐ Check the exemption limits in 21 CFR 862.9 and record the result.
☐ Update registration and device listing.
☐ Confirm design controls, complaint handling and MDR procedures are in place.
☐ Add a review step for marketing and sales claims.
Treat a 510(k) exemption as one less submission, not a smaller QMS. Before launch, write down why the device is exempt, confirm the core quality processes are running, and check every marketing claim against the exempt intended use.
Kapstone Medical provides QMS build and gap assessment support for manufacturers setting up a first quality system.
No. FDA was explicit that exempt devices remain subject to the Quality Management System Regulation (21 CFR 820), along with registration and listing, labeling and medical device reporting. A 510(k) exemption removes one premarket submission; it does not remove any part of the quality system. You still need a documented QMS that meets ISO 13485:2016, which the QMSR incorporates by reference.
The final order covers 14 types of class II toxicology test systems for drugs including amphetamines, cocaine, opiates (which include fentanyl) and cannabinoids. The exemption applies only when the test is intended for employment and insurance testing and its labeling states it is intended solely for that use. FDA did not extend the exemption to oral fluid collection devices or PCP tests. The full list of device types and product codes is in the order (91 FR 63478).
Yes. The QMSR applies ISO 13485:2016's design and development requirements (clause 7.3) to class II devices, so a design file is still required even when the device is 510(k)-exempt. Complaint handling and adverse event reporting also apply from the first sale.
The exemption depends on intended use. If a website, sales deck or distributor begins describing the test for clinical diagnosis or emergency use, the intended use has changed and the exemption may no longer apply under 21 CFR 862.9. Marketing and sales claims need the same review as labeling, so build a review step for them into your process.
Write a short determination that names the classification regulation and product code, states the intended use and records your review of the exemption limits in 21 CFR 862.9. Keep it under document control and update it when labeling or claims change. If the status is still unclear, a 513(g) request lets you ask FDA directly about a device's classification and the requirements that apply.