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  1. Medical Devices News and Events

CDRH Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Medical Devices

FOR IMMEDIATE RELEASE

March 30, 2023

The following is attributed to Brendan O'Leary, Deputy Director of the Digital Health Center of Excellence in the FDA's Center for Devices and Radiological Health

Digital health technologies are playing an increasingly significant role in many facets of our health and daily lives, and Artificial Intelligence and Machine Learning, or AI/ML, is powering important advancements in this field. The FDA has already authorized more than 500 AI/ML-enabled medical devices, and more are under development. Ensuring that these innovative devices are safe and effective, and that they can reach their full potential to help people, is central to the FDA's public health mission.

Today, the FDA is publishing a draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions." This draft guidance proposes a science-based approach to ensuring that AI/ML-enabled devices can be safely, effectively, and rapidly modified, updated, and improved in response to new data.

The approach the FDA is proposing in this draft guidance would put safe and effective advancements in the hands of health care providers and users faster, increasing the pace of medical device innovation in the United States and enabling more personalized medicine. In addition to across-the-board, or "global," device updates, under the proposed approach, AI/ML-enabled devices could be more extensively and rapidly modified to learn and adapt to local conditions. This means, for example, that diagnostic devices could be built to adapt to the data and needs of individual health care facilities and that therapeutic devices could be built to learn and adapt to deliver treatments according to individual users' particular characteristics and needs.

We will continue to assure the safety and effectiveness of AI/ML-enabled devices throughout the total product lifecycle (TPLC), including through a Predetermined Change Control Plan for the device that would be reviewed and agreed to by the FDA. Under the proposal in the draft guidance, a Predetermined Change Control Plan could enable both changes that are implemented manually and changes that are implemented automatically by the software. The plan would include a detailed description of the specific, planned device modifications; a description of the methodology that would be used to develop, validate, and implement those modifications — including describing how necessary information about these modifications will be clearly communicated to users; and an assessment of the benefits and risks of the planned modifications.

CDRH is committed to advancing health equity as an important focus of our 2022-2025 strategic priorities, which affirm that digital health technologies should be designed and targeted to meet the needs of diverse populations. Predetermined Change Control Plans can take this further by facilitating more rapid and continuous improvement of AI/ML-enabled device performance across diverse populations. The approach FDA is proposing in this draft guidance would ensure that important performance considerations, including with respect to race, ethnicity, disease severity, gender, age, and geographical considerations, are addressed in the ongoing development, validation, implementation, and monitoring of AI/ML-enabled devices. Notably, the draft guidance proposes to place a significant and increased emphasis on the importance of clearly communicating valuable information about these considerations to device users.

This draft guidance is informed by the considerable experience the FDA has gained by regulating AI/ML-enabled devices and, in recent years, exploring new regulatory frameworks for digital health medical devices. It builds on a proposed framework for AI/ML Software as a Medical Device that we outlined in our 2019 discussion paper and further described in our AI/ML-Based Software as a Medical Device Action Plan. Notably, in the draft guidance, we are proposing the Predetermined Change Control Plan concept for not only AI/ML-enabled Software as a Medical Device, but for all AI/ML-enabled device software functions, including software functions that are part of or control hardware medical devices.

We look forward to receiving comments on this draft guidance from stakeholders and moving to issue final guidance as part of our ongoing commitment to advance safe and effective medical device innovations for the benefit of public health.

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