|
The Food and Drug Administration (FDA) announced it is seeking public comment on its intent to remove the 510(k) Clearance requirement for federally regulated drug testing programs.
- Current State: Before a laboratory can use a screening assay/reagent in drug testing, FDA requires that the assay/reagent meet the requirements of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360(k). These are more commonly known as FDA’s “510(k) clearance” requirements, “Premarket Notification,” or “PMN”. The only exemption to the 510(k) clearance requirement is when drug testing is related to private employment and insurance. Drug testing programs such as Federal employee drug testing programs and the U.S. Department of Transportation’s industry testing program are not included in the exemption.
- Proposed Change: On May 1, 2026, the FDA published a notice seeking public comment in the Federal Register https://www.govinfo.gov/content/pkg/FR-2026-05-01/pdf/2026-08499.pdf. Specifically, FDA announced its intent to remove the exception to the 501(k) exemption for devices intended for Federal drug testing programs. These Federal drug testing programs include, among others, the programs run by the Department of Transportation.
Currently, laboratories using screening assays for Federal drug testing programs (like for the U.S. DOT drug testing program) must use screening assays that are FDA 510(k) cleared. The FDA proposed change would remove the 510(k) clearance requirement. We believe that employers, employees, and testing service providers involved in the DOT testing program should be aware of the FDA Federal Register notice. We recommend that DOT program participants review the FDA proposal and, if they have views or concerns to express, provide comments to the FDA at https://www.regulations.gov/docket/FDA-2026-N-4268 . Comments are due by June 30, 2026.
| U.S. Department of Transportation | 1200 New Jersey Avenue, SE | Washington DC 20590 | 855-368-4200 |
 |
|
