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

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.
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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.
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