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# Guide on Device Change Control Plans
- URL: https://www.fdaweb.com/guide-on-device-change-control-plans/
- Published: 2024-08-22T12:00:00.000Z
- Updated: 2026-09-14T14:39:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157634

*Federal Register* notice: FDA is making available a draft guidance entitled “Predetermined Change Control Plans for Medical Devices.” The agency says such plans contain documentation describing what modifications will be made to a device and how the modifications will be assessed. The guidance provides FDA’s current thinking on a policy for the change control plans and recommendations on the information to include in a plan submitted as part of a device marketing submission. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-08-22/pdf/2024-18828.pdf?ref=fdaweb.com).