FDA Expresses Need for Greater Post-Market Visibility to Regulate AI/ML-Enabled Medical Devices
Summary
An official from the US Food and Drug Administration (FDA), which has regulatory oversight of medical products that employ AI, recently indicated that the agency needs to implement a process for long-term, post-market surveillance of AI/ML health technologies. Dr. MiRa Jacobs, who is the Assistant Director of Digital Health Policy at the FDA’s Digital Health Center of Excellence, spoke during an Alliance for a Stronger FDA webinar on September 19, 2023, about the FDA’s progress in regulating AI/ML-enabled medical devices. Dr. Jacobs explained that AI is “uniquely and extremely dependent on the data that is used to develop the models,” which implicates concerns regarding bias and requires the FDA to tailor its approach to measuring safety and effectiveness. She expressed confidence that the FDA’s existing approach to premarket review can adequately account for these technologies, but that the review process for post-market surveillance requires further development. Regulators and developers must consider how the models operate as they are clinically integrated and respond to changes in their populations and other factors, which requires long-term visibility post-market. Jacobs added that the agency supports increased harmonization across federal agencies. This sentiment contrasts with recent calls from Senate Health Committee Ranking Member Bill Cassidy (LA) for a sector-by-sector approach to regulating AI/ML technologies.
