The advent of Artificial Intelligence (AI) has heralded a new era in healthcare, promising to transform the development of medical products and enhance patient care. In a bid to harness AI’s potential while ensuring public health and ethical innovation, the U.S. Food and Drug Administration (FDA) has taken a significant step forward. The FDA’s Centers for Biologics Evaluation and Research (CBER), Drug Evaluation and Research (CDER), Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) have jointly published a paper outlining their collaborative efforts in integrating AI into the medical product lifecycle.
At the heart of this collaboration is a shared vision of safeguarding public health and fostering innovation. AI’s role in medical products extends from drug and biological product development to device software, with the potential to revolutionize healthcare delivery. The paper emphasizes the importance of a risk-based regulatory framework that is robust, adaptable, and grounded in state-of-the-art regulatory science tools.
The FDA’s approach to AI in medical products is multifaceted, focusing on four key areas: fostering collaboration, promoting harmonized standards, advancing regulatory approaches, and supporting research related to AI performance evaluation and monitoring. This comprehensive strategy aims to address the complex and dynamic nature of AI technologies, ensuring that they are developed, deployed, and maintained responsibly.
Fostering Collaboration for Public Health
The FDA’s medical product Centers are committed to working closely with developers, patient groups, academia, and global regulators. This collaborative spirit is essential for cultivating a patient-centered regulatory approach that emphasizes health equity. The FDA plans to solicit input from a diverse range of stakeholders, focusing on critical aspects of AI use, such as transparency, explainability, and bias mitigation. Educational initiatives are also in the pipeline to support regulatory bodies and healthcare professionals in navigating the safe and responsible use of AI.
Promoting Harmonized Standards and Guidelines
In the realm of AI and medical products, harmonized standards and best practices are crucial. The FDA’s Centers are dedicated to refining considerations for evaluating the safe and ethical use of AI, identifying best practices for long-term safety monitoring, and developing frameworks for quality assurance. The goal is to ensure that AI-enabled medical products meet safety and effectiveness standards, and that the data used to train AI models are representative and fit for purpose.
Advancing Regulatory Approaches that Support Innovation
The FDA’s medical product Centers are intent on developing policies that provide regulatory predictability and clarity for the use of AI. This includes monitoring and evaluating trends, supporting the development of methodologies for evaluating AI algorithms, and leveraging existing initiatives for the evaluation and regulation of AI in medical products. The FDA is poised to issue guidance on the use of AI in medical product development, providing clarity on predetermined change control plans for AI-enabled device software functions and considerations for regulatory decision-making for drugs and biological products.
Supporting Research on AI Performance Evaluation
To gain insights into AI’s impact on medical product safety and effectiveness, the Centers plan to support demonstration projects. These projects will identify points of bias introduction in AI development and address them through risk management. They will also consider health inequities associated with AI use, promoting equity and ensuring data representativeness.