AI-based medical devices rely on machine learning algorithms that can improve and adapt over time. Unlike traditional software, AI models may require frequent updates to enhance performance, incorporate new clinical data, or refine decision-making processes.The FDA has issued final guidance titled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions." This guidance outlines the FDA's recommendations for including a Predetermined Change Control Plan (PCCP) in marketing submissions for AI-enabled medical devices, aiming to facilitate the iterative improvement of these devices without without the need for additional submissions, while ensuring their safety and effectiveness.
Definition of Predetermined Change Control Plan (PCCP)
A PCCP is a comprehensive plan that device manufacturers include in their marketing submissions, detailing anticipated modifications to an AI-enabled device's software functions. It comprises three primary components:
Description of Modifications: Outlines the specific changes planned for the device's software functions.
Modification Protocol: Specifies the methodology for developing, validating, and implementing the proposed modifications.
Impact Assessment: Evaluates the potential effects of the planned modifications on the device's safety and effectiveness.
By incorporating a PCCP into the initial marketing submission, manufacturers can implement specified modifications without the need for additional submissions, provided these changes adhere to the authorized PCCP.
Importance and Advantages of a PCCP
The integration of a PCCP in the regulatory framework for AI-enabled medical devices offers several significant benefits:
Facilitates Innovation: Allows manufacturers to iteratively improve AI algorithms, enhancing device performance and patient outcomes without undergoing repetitive regulatory submissions.
Regulatory Efficiency: Streamlines the approval process for modifications, reducing administrative burdens and expediting the availability of improved medical devices.
Ensures Continuous Safety and Effectiveness: By predefining modification protocols and impact assessments, PCCPs help maintain the safety and effectiveness of devices throughout their lifecycle.
Types of Changes Suitable for a PCCP
The FDA guidance specifies that certain modifications to AI-enabled device software functions can be included in a PCCP, such as:
Performance Enhancements: Improvements to the device's analytical performance and clinical performance resulting from re-training the AI model based on new data within the intended use population from the same type and range of input signal, including sensitivity, specificity, or predictive capabilities.
Modifications related to device input: This may include changes to data type specifications to include new sources of the same input signal type (such as a new data/imaging acquisition system), or limited modifications related to new types of inputs (e.g., adding new data inputs, such as age). Modifications related to input sources may include updates related to available, compatible software or hardware and device interoperability (e.g., different compatible hardware, updated operating systems, or updated cloud infrastructure).
Expansion of Device Use: Modifications that extend the device's functionality to sub population or clinical scenarios, provided these changes are within the scope of the original intended use.
Changes Not Suitable for a PCCP
Certain modifications are deemed inappropriate for inclusion in a PCCP, including:
Fundamental Alterations: Changes that significantly modify the device's intended use or fundamental technology or would not allow the device to remain substantially equivalent to the predicate device.
Unvalidated Modifications: Updates lacking a well-established methodology for validation and implementation.
High-Risk Changes: Modifications that could introduce significant risks to patient safety or compromise the device's effectiveness.
Components to Include in a PCCP
A well-structured PCCP should encompass the following elements:
Detailed Description of Planned Modifications: Clearly articulate the nature and scope of each anticipated change.
Comprehensive Modification Protocols: Provide robust methodologies for the development, validation, and implementation of each modification, ensuring adherence to quality and safety standards.
Thorough Impact Assessments: Evaluate the potential effects and benefit of each modification on the device's performance, safety, and effectiveness, including risk mitigation strategies.
Method for Submission
Manufacturers should include the PCCP as part of their initial marketing submission to the FDA, whether it be a 510(k) premarket notification, De Novo request, or Premarket Approval (PMA) application. The FDA will review the PCCP alongside the overall device submission to ensure that the proposed modifications can be implemented safely and effectively without necessitating additional marketing submissions.
In summary, By adopting a PCCP framework, companies can accelerate product improvements, reduce regulatory burden, and maintain compliance, ultimately supporting AI-driven advancements in healthcare. Manufacturers should carefully design their PCCP to align with regulatory expectations and leverage FDA's Q-Submission Program (PreSub) for early feedback.
Dalia Givony, Regulatory & Clinical Consulting, provides guidance and support for regulatory compliance with over 20 years of experience in the medical device and IVD fields.
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