# FDA PCCP Compliance Guide

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

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.

## More resources

[Template  
**FDA Predetermined Change Control Plan (PCCP) Template**  
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.  
Read more](/content/white-papers/pccp-template/index.html)

[White Paper  
**A Guide To Implementing CI/CD in Your AI/ML SaMD Projects**  
Learn why CI/CD is crucial for AI/ML SaMD development and how you can transition your organization to CI/CD.  
Read more](/content/white-papers/ci-cd-ai-ml-white-paper/index.html)