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# Medical Device PCCP Guidance
- URL: https://www.fdaweb.com/medical-device-pccp-guidance/
- Published: 2024-08-21T12:00:00.000Z
- Updated: 2026-09-14T14:39:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157620

FDA has published a draft guidance, *Predetermined Change Control Plans for Medical Devices*, with the agency’s current thinking on a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a marketing submission for a device. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-medical-devices?utm%5Fmedium=email&utm%5Fsource=govdelivery) defines PCCPs as the documentation describing what modifications will be made to a device and how the modifications will be assessed.

The draft recommends that a PCCP describe the planned device modifications, the associated methodology to develop, validate, and implement the modifications, and an assessment of the modification’s impact. It says FDA reviews the PCCP as part of a marketing submission for a device to ensure its continued safety and effectiveness without needing additional marketing submissions for implementing each modification described in the PCCP.

Once the draft is finalized, the agency will make conforming Level 2 updates to three other guidances, FDA says.

The draft contains an Introduction, Background, Scope, Guiding Principles for PCCPs, Policy for PCCPs, Types of Modifications, Recommended Content for a PCCP, Examples of Modifications for PCCPs, and a Sample of 510(k) Summary Information Regarding the PCCP.