Opportunity
Federal Register #2026-20448
FDA final order expands 510(k) exemptions for certain clinical toxicology test systems
Buyer
Food and Drug Administration
Posted
October 06, 2026
Identifier
2026-20448
The U.S. Food and Drug Administration issued a final regulatory order concerning 510(k) exemptions for certain clinical toxicology test systems. - Government agency: U.S. Department of Health and Human Services, Food and Drug Administration (FDA). - Action: Expands 510(k) premarket notification exemptions for specified Class II clinical toxicology test systems when intended for use in Federal drug testing programs. - Requirements: The exemptions are subject to applicable limitations, including restrictions on intended use and fundamental scientific technology; FDA also amended related device-classification language in 21 CFR part 862. - Procurement status: This is a regulatory action, not a procurement opportunity or contract award. No vendors, OEMs, products, quantities, or services are identified.
Description
The Food and Drug Administration issued a final order exempting certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to specified limitations. The exemptions apply to additional devices intended for use in Federal drug testing programs within the device types identified in the order. FDA is also amending the classification language in 21 CFR part 862 to reflect the determination. The order is effective October 6, 2026.