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# FDA Proposes 1,003 Devices Exempt from 510(k)
- URL: https://www.fdaweb.com/fda-proposes-1-003-devices-exempt-from-510-k/
- Published: 2017-03-14T12:00:00.000Z
- Updated: 2026-09-14T22:11:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138191

*Federal Register* notice: FDA has announced a list of 1,003 Class 2 devices that the agency is proposing to exempt or partially exempt from premarket notification \[510(k)\] requirements. FDA believes that the devices identified are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. It is publishing the notice and requesting public comment in accordance with streamlined procedures established by the 21st Century Cures Act. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-03-14/pdf/2017-04938.pdf?ref=fdaweb.com).