AI-Enabled Device Software: FDA’s Final Guidance for Predetermined Change Control Plans

FDA's New Guidance on AI-Enabled Medical Devices: What You Need to Know

On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.

Executive Summary

The FDA has released its final guidance on Predetermined Change Control Plans (PCCPs) for AI-Enabled Device Software Functions (AI-DFS) in December 2024. This landmark guidance provides a framework for implementing pre-approved modifications to AI-enabled medical devices without requiring separate authorizations for each change.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence

Key Benefits for Medical Device Manufacturers

• Streamlined approval process for AI/ML device modifications

• Flexibility to implement continuous learning improvements

• Clear framework for managing AI software updates

• Potential for faster market adaptation and product enhancement

Core Components Required for PCCP Submissions

1. Modification Description

   • Specification of automatic vs. manual updates

   • Global vs. local modification implementation

   • Expected frequency of updates

2. Modification Protocol

   • Data management practices

   • Retraining procedures

   • Performance evaluation protocols

   • Communication and monitoring plans

3. Impact Assessment

   • Benefits and risks analysis

   • Risk mitigation strategies

How Medoya Can Support Your PCCP Implementation

Our consulting team can assist with:

1. Strategic Planning

   • Assessment of PCCP applicability to your AI-enabled devices

   • Development of comprehensive PCCP strategies

   • Guidance on choosing appropriate regulatory pathways

2. Technical Documentation

   • Preparation of detailed modification descriptions

   • Development of robust modification protocols

   • Creation of thorough impact assessments

3. Regulatory Navigation

   • Support for pre-submission discussions with FDA

   • Guidance on labeling requirements

   • Assistance with pathway selection (PMA, 510(k), De Novo)

4. Implementation Support

   • Development of data management frameworks

   • Creation of retraining protocols

   • Establishment of performance evaluation criteria

   • Design of user communication strategies

Contact Information

Partner with us to navigate the complexities of FDA's regulations and optimize your medical device development process. Our expertise can help streamline your regulatory compliance while maximizing the potential of your AI-enabled medical devices.