Frequently Asked Questions

Laboratory tests under CLIA fall into three categories: waived, moderate complexity and high complexity, and FDA assigns the category for test systems (42 CFR 493.5(a) and FDA CLIA categorizations page). Moderate complexity includes the subcategory of PPM procedures. The category decides which laboratory requirements apply to the site that runs the test.

Waived tests. Tests waived by regulation under 42 CFR 493.15(c), or cleared or approved for home use, are categorized as waived (42 CFR 493.15 and FDA CLIA categorizations page).

The scorecard. For other tests, FDA reviews the package insert instructions and scores the test from 1 to 3 on each of seven criteria (42 CFR 493.17(a) and FDA CLIA categorizations page):

1. Knowledge.
2. Training and experience.
3. Reagents and materials preparation.
4. Characteristics of operational steps.
5. Calibration, quality control and proficiency testing materials.
6. Test system troubleshooting and equipment maintenance.
7. Interpretation and judgment.

A total score of 12 or less means moderate complexity, and a score above 12 means high complexity (42 CFR 493.17(a)).

Default and waiver requests. A test that does not appear on the published lists is considered high complexity until it is reviewed and categorized (42 CFR 493.17(c)(4)). A manufacturer of a moderate complexity test may ask FDA to categorize it as waived through a CLIA Waiver by Application (FDA CLIA categorizations page).

Timing. FDA categorizes a test after it clears or approves a marketing submission, or on request for legally marketed devices (FDA CLIA categorizations page).

Laboratory certificates. Each laboratory must be CLIA-exempt or hold a CLIA certificate, such as a certificate of waiver, a certificate for PPM procedures, a certificate of compliance or a certificate of accreditation (42 CFR 493.5(c)). A laboratory that performs any high complexity test must obtain a certificate for tests of high complexity (42 CFR 493.25(a)).

Related testing topics. The FAQ on whether employers can drug test on site covers on-site screening, and the FAQ on certified laboratories for drug testing covers confirmation testing.

Device rules. The FAQ on FDA drug test device classification explains how drug test systems are classified.

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.

FDA classifies most drug of abuse test systems as class II devices under 21 CFR Part 862, and most are exempt from 510(k) premarket notification only when intended for employment or insurance testing and within the limits in 21 CFR 862.9. Breath alcohol test systems are class I (21 CFR 862.3050).

Device types by drug. Classification regulations in 21 CFR Part 862, subpart D, include these drug test systems:

Class II with limits. For these class II test systems, the regulation states that the device is not exempt if it is intended for any use other than employment or insurance testing (21 CFR Part 862). The exemption also requires a statement in the labeling that the device is intended solely for use in employment and insurance testing (21 CFR 862.3100 through 862.3870). A device is also not exempt if it has a different intended use or uses a different fundamental scientific technology than a legally marketed device of the same type (21 CFR 862.9).

Breath alcohol. A breath alcohol test system measures alcohol in human breath. It is class I under general controls and exempt from 510(k), subject to 862.9 (21 CFR 862.3050).

Federal programs. FDA's October 2026 order extended the exemptions to devices intended for federal drug testing programs (Federal Register 2026-20448).

Workplace panels. The drugs on a test panel depend on the program. The FAQ on what a non-DOT drug test screens for covers common panels, and the FAQ on urine drug screens explains the specimen type.

Recent change. The FAQ on FDA's 510(k) exemption for federal drug tests explains the October 2026 order.