FDA Expands 510(k) Exemptions to Drug Test Systems for Federal Programs

The Food and Drug Administration (FDA), part of the Department of Health and Human Services (HHS), published a final order in the Federal Register on October 6, 2026 that exempts certain class II clinical toxicology test systems intended for Federal drug testing programs from premarket notification, known as 510(k), requirements. The order is Federal Register document 2026-20448 (91 FR 63478), docket FDA-2026-N-4268, and amends 21 CFR Part 862. It took effect on October 6, 2026.

This is a final order and is in effect now. It finalizes, without changes to the list of device types, the notice of intent FDA published on May 1, 2026 (91 FR 23427).

The full order is available on the Federal Register at Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems.

What the Order Changes

Before this order, the 14 clinical toxicology test system types covered were already exempt from 510(k) requirements when intended for employment and insurance testing, but the exemption did not include devices intended for Federal drug testing programs. Those devices needed FDA clearance before they could be marketed. The earlier partial exemptions were finalized in 2017 and codified on December 30, 2019 (84 FR 71794).

The final order removes that exception. A device in one of the covered types is now exempt from 510(k) requirements even when intended for use in Federal drug testing programs, provided it is intended for employment and insurance testing and its labeling includes a statement that it is intended solely for employment and insurance testing. The general limitations in 21 CFR 862.9 still apply, so a device intended for a different use, or one using a different fundamental scientific technology than a legally marketed device of that type, still needs a 510(k). FDA encouraged manufacturers with questions about whether a specific test system is exempt to discuss it with FDA, for example through a section 513(g) request for information. The order describes Federal drug testing programs as including, for example, those run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT) and the U.S. military.

Test Systems Covered

The order revises paragraph (b) of 14 classification regulations in 21 CFR Part 862:

• Amphetamine (862.3100)
• Barbiturate (862.3150)
• Benzodiazepine (862.3170)
• Cocaine and cocaine metabolite (862.3250)
• Codeine (862.3270)
• Lysergic acid diethylamide, or LSD (862.3580)
• Methamphetamine (862.3610)
• Methadone (862.3620)
• Methaqualone (862.3630)
• Morphine (862.3640)
• Opiate (862.3650)
• Propoxyphene (862.3700)
• Cannabinoid (862.3870)
• Tricyclic antidepressant drugs (862.3910)

In response to comments, FDA stated that fentanyl test systems generally fall under the opiate test system regulation (862.3650) and are included in the exemption. Devices previously designated under the non-exempt product code DJG will fall under the exempt product code PVH if they stay within the limitations of the exemption. FDA will keep the existing product codes but update the exempt product code definitions, and newly exempt devices will move to the corresponding exempt code.

What the Order Does Not Do

FDA stated that it does not administer or implement Federal drug testing programs and does not oversee them. It regulates the test systems used in them. Many commenters described the exemption as a necessary step for oral fluid testing, and some said the same for hair testing. FDA responded that, while the expanded exemptions may facilitate the use of oral fluid testing in Federal drug testing programs, FDA does not oversee those programs and so does not decide whether oral fluid or hair testing may be used in them.

FDA also declined several requests:

• It did not extend the exemption to other device types, such as phencyclidine (PCP) test systems or oral fluid collection devices, which were outside the scope of the May 2026 notice. FDA noted that there are 510(k)-cleared oral fluid collection devices that may be used with test systems for any drug of abuse analyte.
• It declined to adopt a general enforcement discretion policy for labeling or for 510(k) requirements for all test systems used in Federal drug testing programs.
• It declined to prescribe specific wording for the required employment and insurance testing labeling statement.

Exempt devices remain subject to other requirements, including establishment registration, device listing, quality management system, medical device reporting and labeling rules. FDA also pointed out that laboratories testing specimens for Federal programs remain subject to SAMHSA's Mandatory Guidelines and oversight. According to FDA, test systems previously authorized for use in Federal drug testing programs can continue to be used (assuming compliance with other applicable laws), and FDA believes the only effect the order will have on those programs is the possible increase in the number of test systems that may be used in them.

Background and Comments

FDA received comments from approximately 70 commenters on the May 2026 notice during the 60-day comment period that ended June 30, 2026. The commenters included individuals, trade organizations, regulated industry and labor unions. Some supported the change and urged quick action, while others raised concerns about test accuracy and transportation safety. FDA concluded that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of these devices, subject to the stated limitations, and stated that the order contains no new collection of information.