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.