The U.S. Food and Drug Administration (FDA) convened its inaugural Digital Health Advisory Committee (DHAC) meeting on November 20-21, 2024, in Gaithersburg, Maryland. This committee was established to provide expert guidance on regulatory issues related to digital health technologies, with a particular focus on generative artificial intelligence (AI) in medical devices.
Key Discussion Points:
- Premarket Performance Evaluation: The committee examined the types of data and evidence necessary for the FDA to assess the safety and effectiveness of generative AI-enabled devices. Given the evolving nature of foundational models and potential limitations in training data transparency, discussions centered on establishing robust evaluation criteria.
- Risk Management: The potential risks associated with generative AI, such as unintended outputs and biases, were a significant focus. The committee deliberated on implementing controls related to governance, training, feedback mechanisms, and real-world performance evaluations to mitigate these risks.
- Postmarket Performance Monitoring: Ensuring the ongoing safety and effectiveness of AI-enabled devices post-approval was highlighted. Strategies for continuous monitoring, management, and evaluation of device performance and accuracy were discussed to maintain high standards throughout the product lifecycle.
Committee Composition:
The DHAC comprises nine voting members with diverse expertise in digital health, machine learning, clinical informatics, and healthcare innovation. Dr. Ami B. Bhatt, Chief Innovation Officer at the American College of Cardiology, serves as the chairperson.
Public Engagement:
The FDA has established a public docket (FDA-2024-N-3924) to solicit comments on the topics discussed during the meeting. Stakeholders are encouraged to submit their feedback by January 21, 2025, to inform future regulatory considerations.
This inaugural meeting marks a significant step in the FDA’s efforts to adapt its regulatory framework to the rapidly evolving landscape of digital health technologies, ensuring that innovations in AI are effectively integrated into healthcare while maintaining patient safety and device efficacy.
