Skip to main content
White Paper

FDA PCCP Compliance Guide

Learn more about the FDA's guidance on PCCPs (Predetermined Change Control Plans) for AI/ML-enabled medical device software.
No items found.

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.
    • Get the 
    White Paper

    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
    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
    White Paper

    Test White Paper

    This is a test
    Read more
    White Paper

    Modernizing FDA-Grade Software Development with Validated DevOps

    Discover how Validated DevOps can help you develop software faster while staying compliant.
    Read more