Data / Federal rules / 2026-20448
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems
The Food and Drug Administration published this final rule in the Federal Register on October 6, 2026. It took effect on October 6, 2026.
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What the agency says
The Food and Drug Administration (FDA) is publishing an order setting forth its final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k) requirements, subject to certain limitations, is immediately in effect for such devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is amending the classification language within the Code of Federal Regulations (CFR) for certain class II clinical toxicology test systems to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Key facts
- Document number
- 2026-20448
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- October 6, 2026
- Takes effect
- October 6, 2026
- Dates
- This order is effective October 6, 2026.
- Docket
- Docket No. FDA-2026-N-4268
- Code of Federal Regulations
- 21 CFR 862
- Topics
- Medical devices
- Pages
- 10
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Published in October 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.