How the FDA’s Predetermined Change Control Plan (PCCP) Framework Supports AI-Enabled Medical Devices

25 Mar 2025

Enabling Continuous Innovation While Ensuring Safety and Effectiveness in AI-Driven Healthcare Solutions

The U.S. Federal Drug Administration (FDA) released its final guidance “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” (AI-DSFs) in December 2024. This long-anticipated guidance refines and formalizes the FDA’s expectations for how manufacturers of AI-enabled medical devices can plan, validate, and implement modifications while maintaining compliance and ensuring patient safety.

This guidance introduces the concept of a predetermined change control plan (PCCP), which provides a structured, pre-approved approach for managing software updates in AI-enabled medical devices without requiring additional marketing submissions for each modification. By facilitating iterative development, the PCCP allows manufacturers to innovate quickly while maintaining the safety and effectiveness of their AI-driven technologies.

The FDA outlines three essential components that manufacturers must include in a PCCP. The first is a Description of Modifications, which requires manufacturers to define anticipated changes, including their scope and alignment with the device’s intended use. This ensures transparency in how the AI software will evolve over time. The second component, the Modification Protocol, establishes the methodologies for developing, testing, validating, and implementing changes. This includes protocols for data collection, algorithm retraining, and performance verification to ensure safety and efficacy. Finally, the Impact Assessment evaluates potential risks and benefits of the planned modifications, along with strategies to mitigate risks. This assessment ensures that updates do not compromise device performance or patient safety.

Generally, the recommendations in this guidance apply to the device constituent part of device-led combination products, when the device constituent part includes an AI-DSF. The recommendations in this guidance do not apply to the drug or biologic constituent part of device-led combination products. The PCCP is reviewed and approved during the initial marketing submission process, allowing manufacturers to implement specified updates without submitting new applications for each change. It is important to note that minor updates that do not affect safety or effectiveness are not covered under the PCCP framework and should instead follow Quality System Regulation (QSR) requirements for software maintenance.

To ensure alignment with regulatory expectations, the FDA strongly encourages manufacturers to engage with the agency early in the PCCP development process. The Q-Submission Program provides an opportunity for manufacturers to seek feedback before submitting a PCCP, helping clarify regulatory requirements and expectations. In addition, the guidance reinforces the importance of robust quality management systems. Manufacturers must implement strong data governance, design controls, and version tracking processes to ensure compliance and smooth implementation of PCCP modifications.

Transparency is a critical component of the PCCP framework. The FDA requires clear device labeling for AI-enabled devices that utilize an approved PCCP. The labeling should indicate that the device operates under an authorized PCCP and include descriptions of implemented modifications and their impact on device functionality. Updated performance metrics and revised instructions for use should also be included to ensure healthcare providers and end-users remain informed about how the AI-enabled device is evolving over time.

The PCCP offers several advantages for manufacturers of AI-enabled medical devices. By eliminating the need for repeated marketing submissions for approved updates, it reduces regulatory delays and allows for continuous innovation while maintaining compliance. The framework ensures patient safety by implementing structured, pre-approved change protocols that maintain device effectiveness over time.

While the PCCP provides a pathway for streamlined AI-driven innovation, manufacturers must be prepared to address key challenges. Planned modifications must undergo rigorous risk evaluations to ensure they do not introduce safety concerns. Extensive documentation is required within the PCCP submission to ensure clarity and compliance. Additionally, adherence to ISO 13485, QSR requirements, and recognized AI validation standards is critical for integrating PCCP processes effectively.

Manufacturers can improve their PCCP implementation by engaging with regulators early to align their plans with FDA expectations. Collaboration between AI developers, regulatory experts, and quality assurance teams ensures that all aspects of the PCCP are addressed. Establishing robust validation protocols is also essential to ensure AI updates consistently meet safety and performance benchmarks.

The FDA’s final guidance on PCCPs reflects a broader shift toward adaptive, lifecycle-based regulatory oversight. By enabling structured, continuous improvements, the framework ensures that AI-enabled medical devices can evolve without compromising safety. For manufacturers, early adoption of PCCPs provides a competitive advantage, demonstrating a commitment to both regulatory excellence and technological leadership. In a fast-moving AI landscape, streamlined regulatory compliance can enhance market responsiveness and improve partnerships with healthcare organizations.

Key Takeaways

The FDA’s final guidance on PCCPs for AI-enabled medical devices provides a regulatory framework that balances innovation and patient safety. By adopting a proactive, structured approach to AI software modifications, manufacturers can implement updates efficiently while maintaining compliance with FDA requirements. To succeed, manufacturers should prioritize early engagement with the FDA, establish rigorous risk management protocols, and maintain strong quality systems. As the regulatory landscape continues to evolve, organizations that embrace the PCCP framework will be well-positioned to drive innovation while ensuring the highest standards of safety and effectiveness in AI-driven healthcare solutions.