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# FDA PCCP Compliance Guide

Learn more about the FDA's guidance on PCCPs (Predetermined Change Control Plans) for AI/ML-enabled medical device software.

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[](https://www.ketryx.com/white-papers/fda-pccp-compliance-guide#) [](https://www.ketryx.com/white-papers/fda-pccp-compliance-guide#)

The FDA's guidance on Predetermined Change Control Plans (PCCPs) aims to streamline regulatory processes for AI/ML-enabled medical devices. The guidance allows manufacturers to make software updates without requiring new premarket submissions, fostering innovation while maintaining safety and effectiveness.

In this compliance guide, you'll learn:

**How to streamline AI/ML-enabled device updates**: The PCCP allows manufacturers to update and refine AI/ML algorithms without additional premarket submissions, reducing regulatory burden while ensuring safety and effectiveness.
**Key components of a PCCP**: The guide outlines the three critical sections of a PCCP: Description of Modifications, Modification Protocol, and Impact Assessment, providing manufacturers with clear guidelines for implementing software changes.
**How Ketryx supports PCCP compliance**: Ketryx offers tools that help manufacturers release software faster by automating documentation, ensuring traceability, and integrating modern development practices like Jira and GitHub to meet FDA compliance requirements.

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## More resources

[Template\\
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**FDA Predetermined Change Control Plan (PCCP) Template**\\
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This template is designed to assist organizations in developing a comprehensive plan to manage and assess modifications to Machine Learning Device Software Functions (ML-DSFs) in medical devices.\\
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Read more](https://www.ketryx.com/white-papers/pccp-template)

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**A Guide To Implementing CI/CD in Your AI/ML SaMD Projects**\\
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Learn why CI/CD is crucial for AI/ML SaMD development and how you can transition your organization to CI/CD.\\
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**Modernizing FDA-Grade Software Development with Validated DevOps**\\
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Discover how Validated DevOps can help you develop software faster while staying compliant. \\
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Read more](https://www.ketryx.com/white-papers/validated-devops-white-paper)