On March 15, 2024: The US Food and Drug Administration (FDA) took a significant step forward in the realm of medical innovation with the publication of a comprehensive white paper, titled “artificial intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This document provides valuable insights into the FDA’s broad perspective on deploying and regulating artificial intelligence (ai) throughout the life cycle of medical products.
Executive Order 14110 and Beyond:
Issued in response to the Executive Order 14110, which was signed in October 2023, this white paper is an early look into the potential policy framework guiding ai application in healthcare and human services. The FDA’s focus areas include drug and device safety, public health, and biological products.
Medical Products: A Broad Scope
Collaborative Efforts:
The white paper emphasizes the collaborative efforts of four FDA centers: Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP). Together, they aim to foster innovation, develop harmonized standards, and support research in the realm of ai.
Amplifying Collaboration
Promoting Discourse:
Collaboration is at the heart of these ambitious plans. The FDA intends to engage various stakeholders, including ai developers, patient groups, and international regulators, in shaping a future where ai plays an integral role in healthcare. The FDA will host workshops, publish draft guidance documents, and propose rules to gather feedback on critical topics like cybersecurity and quality assurance.
Boosting Medical ai Advancements
Clear Regulatory Policies:
The FDA will adapt to the fast-paced ai development by closely monitoring trends and making timely adjustments. This proactive approach aims to ensure seamless integration of new medical ai advancements within regulatory frameworks, making data and observation the driving forces behind regulation rather than rigid policies.
Refining Good ML Practices
Good Machine Learning Practices (GMLP):
The white paper underscores the need to refine and develop GMLP for medical device development. International regulatory bodies, such as the IMDRF, will play a crucial role in promoting harmonized standards and guidelines for ai integration into medical product development and post-market safety.
The FDA Channels Collaboration
International Engagement:
Engaging with international counterparts, such as Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), is a key component of the FDA’s strategy. The IMDRF could be instrumental in combining resources and insights to advance GMLP.
Safety and Efficacy:
The FDA prioritizes safety and efficacy by testing ai in clinically relevant conditions and ensuring that clinical study participants and data sets accurately represent the intended patient population.
