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Predetermined Change Control Plans for Medical Devices, Draft (FDA, Aug 2024)

FDA

Predetermined Change Control Plans for Medical Devices, Draft (FDA, Aug 2024)

FDA's draft guidance extending PCCPs to all devices, with examples of changes that fit and changes that need a new submission.

August 2024

Published

FDA

Source

Topic

https://cdn.prod.website-files.com/5f10960649ee0832d2b92042/6ad697111e41589407e5d2ce_download.pdf

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Predetermined change control plans for medical devices

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