510(k)-Exempt Does Not Mean QMS-Exempt

Introduction

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.

Key Takeaways:

• The exemption is narrow and conditional: FDA's October 6, 2026 final order removes the 510(k) requirement for 14 types of class II drug-screening tests, but only when the test is intended for employment and insurance testing and its labeling says so. Oral fluid collection devices and PCP tests are not included.
• The QMS does not shrink: Exempt devices remain subject to registration and listing, labeling, the Quality Management System Regulation (21 CFR 820) and medical device reporting. The exemption removes one submission, not any part of the quality system.
• Design controls still apply: Because these are class II devices, the QMSR applies ISO 13485:2016's design and development requirements (clause 7.3), so a design file is still required.
• Change the intended use can remove the exemption: If marketing, a sales deck or a distributor describes the test for clinical diagnosis or emergency use, the intended use changes and the exemption may no longer apply (21 CFR 862.9). Claims need the same review as labeling.
• Write down the exemption rationale: A short, document-controlled determination naming the regulation and product code, the intended use and the review of exemption limits answers the question in an inspection or due diligence. A 513(g) request is available if the status is unclear.

What changed

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.

What did not change

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.

• Design controls. The QMSR applies the standard's design and development requirements (clause 7.3) to class II devices, so a design file is still required.
• Complaint handling and adverse event reporting from the first sale.

Where startups get caught

• Claims drift. The exemption depends on intended use. If a website, sales deck or distributor starts describing the test for clinical diagnosis or emergency use, the intended use has changed and the exemption may no longer apply (21 CFR 862.9). Marketing claims need the same review as labeling.
• A QMS sized to the submission. Some teams reason that no 510(k) means a short list of procedures. The QMS should be sized to the device class and its risks instead. A small team can keep procedures short and forms simple, but every required process has to exist and be followed.
• No written status decision. It is easy to skip writing down why a device is exempt. A short determination that names the regulation and product code, states the intended use and records the review of the exemption limits answers the question when it comes up in an inspection or due diligence. Keep it under document control and update it when labeling or claims change.

Quick checklist

☐  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.

Recommendation

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.

Frequently Asked Questions

Does a 510(k) exemption mean I don't need a 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.

Which drug-screening tests does the October 2026 exemption cover?

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).

Do design controls still apply to an exempt class II test?

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.

What happens to the exemption if our marketing claims change?

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.

How do we document that our device qualifies as exempt?

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.

Sources

1. FDA final order, 91 FR 63478 (October 6, 2026), including the full list of device types and product codes: https://www.federalregister.gov/d/2026-20448
2. 21 CFR Part 820 (QMSR), sections 820.7 and 820.10, eCFR: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
3. 21 CFR 862.9, limitations of exemptions, eCFR: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-862/subpart-A/section-862.9
4. FDA, Class I and Class II Device Exemptions: https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions
5. FDA guidance, Section 513(g) Requests for Information (August 2024): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic

Additional Resources

• Quality Management System
• Gap Analysis
• Regulatory Strategy