U.S. FEDRegulation
FDA exempts certain class II clinical toxicology tests from 510(k) review
The Food and Drug Administration published a final order exempting certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. The exemption is immediately in effect, and FDA said it will decrease regulatory burdens on the medical device industry and eliminate private compliance costs. FDA amended the classification language in the Code of Federal Regulations for those devices to reflect the determination.
Key points
- Exempts certain class II clinical toxicology test systems from 510(k) premarket notification, with limitations.Federal Register
- Exemption is immediately in effect as of October 6, 2026.Federal Register
- FDA says the move decreases regulatory burdens on the device industry.Federal Register
- CFR classification language amended to reflect the final determination.Federal Register
- The final order was published at 91 FR 63478 (FR Doc. 2026-20448).Federal Register
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RegulationU.S.FDA Final Order: Exemption of Certain Clinical Toxicology Test Systems From Premarket Notification (2026)HealthcareFor practitionersFor governance