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# Guide on 510(k)s for Device Changes
- URL: https://www.fdaweb.com/guide-on-510-k-s-for-device-changes/
- Published: 2017-10-26T12:00:00.000Z
- Updated: 2026-09-14T22:58:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139971

*Federal Register* notice: FDA has made available a guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device” that clarifies when a change in a legally marketed medical device would require a 510(k) submission. The document supersedes a similar guidance issued in 1997\. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-25/pdf/2017-23197.pdf?ref=fdaweb.com).