Technology · 06/10/2026Updated: 10/17/2026 · 1 min read

FDA Exempts Certain Class II Clinical Toxicology Test Systems from Premarket Notification Requirements

The Food and Drug Administration (FDA) has made a final determination to exempt certain class II clinical toxicology test systems from the need for a premarket notification (510(k)) prior to their marketing in the US, following a review of the devices' safety and effectiveness.