Artificial Intelligence and Machine Learning in Software as a Medical Device

The FDA is evolving its regulatory framework to address the unique challenges posed by Artificial Intelligence (AI) and Machine Learning (ML) in medical devices, particularly Software as a Medical Device (SaMD). Recognizing the limitations of traditional regulatory approaches for these rapidly advancing technologies, the FDA has introduced targeted initiatives and collaborative efforts.

Key Initiatives and Plans

AI/ML SaMD Action Plan:

• Outlines a framework for premarket review and postmarket modifications of AI/ML-driven SaMD, ensuring safety and efficacy while accommodating technological advancements.

Discussion Papers:

• Provide insights into potential regulatory strategies and invite stakeholder input to shape policies.

Coordinated Approach

FDA Collaboration Across Centers:

• 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) are working together under the initiative “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together”
• Focuses on aligning regulatory efforts and sharing knowledge to address AI applications in medical products comprehensively.

Stakeholder Engagement

• The FDA encourages stakeholders to engage with their digital health resources for updates or questions regarding AI, ML, or digital health regulatory policies.

This adaptive regulatory approach demonstrates the FDA’s commitment to fostering innovation while ensuring patient safety and product efficacy in the dynamic landscape of AI-driven medical devices.

Region: United States of America

Source: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device