The FDA’s Pre-determined Change Control Plan (PCCP): A Useful Tool to Reduces Repeat Submissions

The FDA issued draft guidance for PCCP for AI-enabled devices on April 3, 2023, followed by draft guidance for PCCP for all medical devices in August 2024, and final guidance for PCCP in December 2024. PCCP is a great tool for continued innovation while reducing regulatory burden and time delays due to repeat submissions. This is especially beneficial for diagnostic and software-based products with frequent changes, where continued algorithm training improves performance and fosters innovation. This also enables the use of Real-World Data (RWD) for model retraining or validation as part of modification plans.

Tracing PCCP back further to December 2022, the Food and Drug Omnibus Reform Act (FDORA) was signed into law with the aim of modernizing FDA regulations and processes across several areas including drug development, device regulation, and patient access to treatments. The Act was created with the intention of updating regulatory pathways to incorporate modern scientific tools, technologies, and approaches. Section 3308 of FDORA explicitly addresses the need for PCCPs to manage post-market updates to medical devices, including AI/ML-enabled devices.

When it comes to effectively implementing PCCPs into industry, planning and thinking ahead are paramount to a company’s success. Organizations with a robust planning culture are in a great position to benefit from this tool. PCCPs are submitted as a part of marketing submissions and are authorized as a part of marketing authorizations such as 510(k), de novo, or PMA. With proper planning of potential changes and how they would impact a submission, the chance for a required resubmission falls drastically. To further increase the likelihood of successful implementation, it is recommended that the potential PCCPs be discussed as a part of the Q-submission process.

Potential changes include but are not limited to:

• Software changes that do not change intended use, introduce new risks, or modify the original risks.

• Instrument upgrades within the same device family or addition of another serialized instrument for single-site submission.

• Material or reagent supplier changes that may improve performance but do not change safety or risk profile.

• Modifications related to quantitative measures of AI-DSF (Artificial Intelligence - Device Software Function) performance specifications.

• Modifications related to device inputs to, and compatibility with, the AI-DSF.

• Certain modifications related to the device’s use and performance (e.g., for use within a specific subpopulation).

Any deviation from the authorized PCCP may trigger review and regulatory repeat submissions. Any modifications as per authorized PCCP could be documented as part of the quality system without going through additional regulatory submissions. Implementing proper planning and design control will facilitate the implementation of an effective PCCP process, reducing significant regulatory burden and expediting time to market. Additionally, in January 2025, the FDA issued draft guidance for Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendation. This document further emphasizes TPLC (Total Product Life Cycle), Design Control, and PCCP. Going forward it is highly recommended that these guidance documents be considered an essential part of the product development plan and process, especially if the device in question is based on software.

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