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# Guidance on 510(k)s for Changes to Existing Device
- URL: https://www.fdaweb.com/guidance-on-510-k-s-for-changes-to-existing-device/
- Published: 2016-08-08T12:00:00.000Z
- Updated: 2026-09-14T21:22:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136444

*Federal Register* Notice: FDA is making available a draft guidance entitled *Deciding When to Submit a 510(k) for a Change to an Existing Device*. FDA intends to clarify when a change in a legally marketed medical device would require that a manufacturer submit a premarket notification (510(k)) to FDA. When finalized, this document will supersede Deciding When to Submit a 510(k) for a Change to an Existing Device'' issued January 10, 1997\. To download this guidance, click [here.](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514771?ref=fdaweb.com) To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-08/pdf/2016-18713.pdf?ref=fdaweb.com)