Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers

Document 2025-11207 is a Final Rule published by the Food and Drug Administration in the Federal Register on June 18, 2025, with an effective date of June 18, 2025. 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). View the original at https://www.federalregister.gov/documents/2025/06/18/2025-11207/medical-devices-exemptions-from-premarket-notification-class-ii-devices-clinical-electronic.

No. Document 2025-11207 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.