FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical Devices
核心洞察
The FDA has finalized guidance on predetermined change control plans (PCCPs) for AI-enabled medical device software functions, aiming to streamline iterative development.
PCCPs allow developers to plan for modifications to AI-enabled devices while ensuring safety and effectiveness through a structured methodology for validation and implementation.
The guidance specifies that changes consistent with an approved PCCP do not require a new 510(k) submission or a PMA supplement, reducing regulatory burden.
The Food and Drug Administration (FDA) has issued final guidance on predetermined change control plans (PCCPs) for artificial intelligence (AI)-enabled medical device software functions. This guidance aims to provide a framework for managing modifications to these devices while maintaining reasonable assurance of safety and effectiveness.
The FDA recognizes that AI-enabled device development is an iterative process. PCCPs are designed to allow developers to plan for modifications, ensuring continued safety and effectiveness. A PCCP should include planned modifications, a methodology to develop, validate, and implement these modifications, and an assessment of their impact.
The concept of PCCPs was initially introduced in a 2019 white paper and further solidified by the Food and Drug Omnibus Reform Act of 2022 (FDORA). FDORA stipulates that a supplemental application for a device that received Pre-Market Approval (PMA) or a new 510(k) is not required for a change to a device if the change aligns with an FDA-approved or cleared PCCP.
This final guidance is specifically tailored to AI-enabled devices. However, the FDA notes that PCCPs can be submitted for other types of devices. The FDA has also issued draft guidance that applies more broadly to all devices, indicating a wider applicability of the PCCP concept.