A general framework for governing marketed AI/ML medical devices.

Journal: NPJ digital medicine
Published Date: May 31, 2025

Abstract

This project represents the first systematic assessment of the US Food and Drug Administration's postmarket surveillance of legally marketed artificial intelligence and machine learning based medical devices. We focus on the Manufacturer and User Facility Device Experience database-the FDA's central tool for tracking the safety of marketed AI/ML devices. In particular, we evaluate the data pertaining to adverse events associated with approximately 950 medical devices incorporating AI/ML functions for devices approved between 2010 through 2023, and we find that the existing system is insufficient for properly assessing the safety and effectiveness of AI/ML devices. In particular, we make three contributions: (1) characterize the adverse event reports for such devices, (2) examine the ways in which the existing FDA adverse reporting system for medical devices falls short, and (3) suggest changes FDA might consider in its approach to adverse event reporting for devices incorporating AI/ML functions.

Authors

  • Boris Babic
    INSEAD, Singapore and Fontainebleau, France.
  • I Glenn Cohen
    The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, The Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL), Cambridge, MA, USA. igcohen@law.harvard.edu.
  • Ariel Dora Stern
    Harvard Business School and the Harvard-MIT Center for Regulatory Science, Morgan Hall 433, 15 Harvard Way, Boston, MA 02163, USA.
  • Yiwen Li
    College of Polymer Science and Engineering, National Key Laboratory of Advanced Polymer Materials, Sichuan University, Chengdu 610065, China. xuyt@scu.edu.cn.
  • Melissa Ouellet
    Digital Health Cluster, Hasso Plattner Institute, Potsdam, Germany.

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