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# Guide to Exempt ‘Well Understood’ Devices from 510(k)
- URL: https://www.fdaweb.com/guide-to-exempt-well-understood-devices-from-510-k/
- Published: 2019-02-08T12:00:00.000Z
- Updated: 2026-09-15T01:01:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143338

FDA has released a guidance entitled “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.” The agency says the devices identified in the guidance are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness. Until the publication of a final rule exempting these devices from 510(k), FDA notes it does not intend to enforce compliance with 510(k) requirements for these devices.