Federal Register #FDA-2026-N-4268

FDA Proposes Exemption for Certain Class II Clinical Toxicology Devices from 510(k) Requirements

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is seeking public input on a proposal to exempt certain class II clinical toxicology test system devices from premarket notification (510(k)) requirements. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Products/Services Requested: - Exemption from 510(k) premarket notification for specified class II clinical toxicology test system devices - Applies to devices intended for employment and insurance testing - Devices must meet FDA general and partial limitations and include appropriate labeling - OEMs and Vendors: - No specific OEMs or vendors are named in this notice - Unique/Notable Requirements: - Exemption is limited to devices meeting specific use cases and labeling requirements - Public comments are requested before a final determination is made - No individual products, part numbers, or quantities are specified

Description

The Food and Drug Administration (FDA) is announcing its intent to exempt from premarket notification requirements certain class II clinical toxicology test system devices. This notice is published to request public comment in accordance with the 21st Century Cures Act. The exemption aims to reduce regulatory burdens by eliminating the need for 510(k) submissions for these devices, provided they meet specified limitations. Comments on this proposal must be submitted by June 30, 2026, and the FDA will consider these comments before making a final determination.

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