# FDA Predetermined Change Control Plan (PCCP): Compliance Guide Lee Chickering May 9, 2024 In April of 2023, the FDA published the draft guidance “[Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial).” In this preliminary guidance, the FDA presented a forward-thinking strategy rooted in scientific principles to guarantee the safe, efficient, and swift adaptation, enhancement, and refinement of AI/ML-powered devices. Although all of this sounds intimidating, our goal is to break down the most significant parts of the Predetermined Change Control Plan (PCCP) for manufacturers to better understand this complex guidance. ## **What is a Predetermined Change Control Plan (PCCP)?** .png) The Predetermined Change Control Plan (PCCP) is an innovative approach to address ML-related risk in premarket submissions for medical devices. This plan empowers manufacturers to refine and tune AI/ML algorithms through frequent deployments within the constraints of safety and effectiveness without the need to make an additional premarket submission. What does this mean in practical terms? It translates to a significant reduction in time and resources required by manufacturers and regulators in preparing and reviewing premarket submissions for software changes. The utilization of PCCP is meant to reduce regulatory burden by providing the means for real-time improvements in devices in the postmarket phase. The flexibility to adapt and enhance without excessive bureaucratic hurdles is pivotal in enabling advancements in medical device technology. In order to understand the PCCP, it's vital to understand why it is necessary in the AI/ML space. Artificial intelligence (AI) and more specifically machine learning (ML) is a new and powerful tool companies around the world are beginning to integrate into their medical device systems to be more efficient and productive. The FDA recognizes the importance of AI/ML in the medical industry and is trying to create a process to allow companies to develop safe and effective medical devices that use ML models developed with ML algorithms. Since, by definition, ML-DSFs are constantly changing and improving, the FDA has created the PCCP guidance to allow medical device manufacturers to follow these guidelines instead of constantly creating new submissions for medical device modifications that would otherwise require a premarket approval supplement, such as a Special 510(k), De Novo request, or PMA supplement. In the FDA’s words, “This draft guidance proposes a least burdensome approach to support iterative improvement through modifications to an ML-DSF while continuing to provide a reasonable assurance of device safety and effectiveness.” ## **How to Create a PCCP** The PCCP draft guidance includes three main sections: - **Description of Modifications:** Itemization of the proposed device modifications, along with specific justifications for the ML-DSF modifications. - **Modification Protocol:** Describes the means, methods, and manner to develop, validate, and implement these changes. - **Impact Assessments:** Entails documenting the evaluation of benefits and risks associated with implementing a PCCP for an ML-DSF, along with strategies to mitigate those risks. ## **PCCP Description of Modifications** **Purpose of a Description of Modifications** This section is a description of each planned modification to an ML-DSF in the PCCP as either a stand-alone submission or in concert with a “new” premarket submission. **How to Complete a Description of Modifications** Modifications to the PCCP that are difficult to verify and validate may impact the approval of the PCCP. By limiting the number of modifications, the FDA can concentrate their review efforts on a defined set of changes. This focused approach enables thorough scrutiny and assessment of each modification's impact on the device's performance, safety, and effectiveness. The Description of Modifications should itemize the proposed device modifications, along with specific justifications. It is essential to indicate if the modifications are automatic (implemented by software) or manual (requiring human intervention). ## **PCCP Modification Protocol** ### **Purpose of Modification Protocol** The purpose of the Modification Protocol is to establish a comprehensive set of procedures delineating the step-by-step process for implementing the aforementioned modifications while ensuring continued device safety and effectiveness. ### **How to Complete the Modification Protocol** The goals of the Modification Protocol include documenting the methods and data used to develop, validate, and implement all proposed modifications. ## **PCCP Impact Assessment** ### **Purpose of the PCCP Impact Assessment** The Impact Assessment entails documenting the evaluation of benefits and risks associated with implementing a PCCP, along with strategies to mitigate those risks. The manufacturer conducts this assessment within the existing quality system framework. ### **How to Complete the PCCP Impact Assessment** Manufacturers should document how individual modifications affect not only the ML-DSF but also the device's overall functionality. ## **What Do Medical Device Companies Need to Know About PCCP Submissions?** The PCCP process involves a periodic regulatory review of the manufacturer’s plan for maintaining the safety and effectiveness of a device. ## **How Ketryx Can Help Manufacturers & Developers with their PCCP** Ketryx helps companies release software faster and in accordance with their PCCP by enabling developers to utilize modern development tools and practices while equipping quality teams with automated documentation and testing. ## **FDA Predetermined Change Control Plan (PCCP) Template** Ketryx has built an in-depth PCCP template for manufacturers and companies looking to produce an FDA-compliant PCCP. This template explains the step-by-step instructions and procedures for each of the three components of the PCCP along with an example product.