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# FDA Exempts 71 Class 1 Devices from 510(k) Submissions
- URL: https://www.fdaweb.com/fda-exempts-71-class-1-devices-from-510-k-submissions/
- Published: 2017-04-13T12:00:00.000Z
- Updated: 2026-09-14T22:17:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138445

*Federal Register* notice: FDA has identified 71 Class 1 devices that are now exempt from premarket notification requirements, subject to certain limitations. The agency believes that the device types are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. The listing is being published according to streamlined procedures established by the 21st Century Cures Act. Unlike Class 2 device types, the Act does not require the agency to solicit feedback on the Class 1 list. However, interested persons can submit comments about this notice by contacting **Bryce Bennett** (Bryce.Bennett@fda.hhs.gov). To view the notice, click [here](https://www.federalregister.gov/documents/2017/04/13/2017-07468/medical-devices-exemptions-from-premarket-notification-class-i-devices?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery).