In a just-released guidance by the U.S. Food and Drug Administration (FDA) regarding lifecycle management of AI-enabled medical devices entitled Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions, the agency offers crucial recommendations on how to help make the safe development of effective AI-based medical products possible. The guidance was released on December 4, 2024. It is intended to support the streamlined and forward-thinking regulation of AI and ML technologies in healthcare.

The new guidance explains how to prepare marketing applications for devices with AI-enabled software functions, taking a flexible approach in handling future changes. Notably, the FDA has stated that developers of AI-enabled devices will not be required to file completely new marketing applications for changes made under an approved PCCP. This permits continual adaptation of the software functions of these products in ways that are not necessarily to trigger a full review process if changes fit the pre-approved PCCP.

This is a regulatory approach aimed at the fast-changing nature of AI and ML technologies, yet one that provides safety and efficacy. When FDA officials recognized that some modification of the AI software is anticipated, they said the agency would concentrate its review on the most significant changes and recommended that the applicant submit documentation with tracked changes to facilitate this process.

To further buttress the stakeholders of industry, the FDA has scheduled a webinar for January 14, 2025, whereby the agency will provide further insights to the finalized guidance. In doing this, the FDA takes another leap toward advancing its regulatory science while promoting innovation while having the strictest safety standards.

FDA’s Guidelines

The finalized guideline is part of the broad efforts of the FDA for facilitating the faster deployment of devices empowered by AI. On the one hand, FDA considers factors like race, ethnicity, gender, and the severity of disease while constantly developing and monitoring AI/ML medical devices. The basic purpose of these considerations will be to enhance the performance as well as inclusiveness of AI technologies in a range of patient populations.

In relation to the above, these recommendations were said to include AI-enabled devices reviewed from either the 510(k) pathway, De Novo, and PMA by FDA.