Data / Federal rules / 2025-11207
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers
The Food and Drug Administration published this final rule in the Federal Register on June 18, 2025. It took effect on June 18, 2025.
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What the agency says
The Food and Drug Administration (FDA, we, or the Agency) is publishing an order setting forth the Agency's final determination to exempt certain class II clinical electronic thermometers from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for such class II clinical electronic thermometers. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulations. FDA is amending the classification language within the Code of Federal Regulations for certain class II clinical electronic thermometers 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
- 2025-11207
- Type
- Final rule
- Action
- Final amendment; final Order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- June 18, 2025
- Takes effect
- June 18, 2025
- Dates
- This order is effective June 18, 2025.
- Docket
- Docket No. FDA-2023-N-4372
- Code of Federal Regulations
- 21 CFR 880
- Topics
- Medical devices
- Pages
- 3
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Published in June 2025
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.