Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirem
The Food and Drug Administration (FDA) is announcing the availability of the guidance "Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements." This guidance describes FDA's intent to exempt certain unclassified medical devices from premarket notification requirements. At this ti
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-06-05 |
| Summary | The Food and Drug Administration (FDA) is announcing the availability of the guidance "Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements." This guidance describes FDA's intent to exempt certain unclassified medical devices from premarket notification requirements. At this time, and based on the information currently available to the Agency, FDA believes the devices identified in this guidance meet the standards for exemption from premarket notification. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices. |
| Document number | 2026-11303 |
| Official record | https://www.federalregister.gov/documents/2026/06/05/2026-11303/intent-to-exempt-certain-unclassified-medical-devices-from-premarket-notification-requirements |