Sep 24, 2021

The US Food and Drug Administration has published an initial list of legally marketed medical devices that utilize artificial intelligence and machine learning (AI/ML) in order to provide more transparency to stakeholders and the public regarding increasing use of these technologies in healthcare settings.

The list covers AI/ML devices that have either obtained 510(k) clearance, Premarket Approval (PMA) or De Novo request acceptance from FDA. The list currently contains 343 devices, and the agency plans periodic updates depending on publicly available information and data.

For each AI/ML device on the list, FDA provides information including:

  • Date of final regulatory decision
  • Premarket application submission number
  • Device name
  • Manufacturer name
  • Lead panel associated with device
  • Primary product code

FDA’s AI/ML device list follows publication of the agency’s in-depth AI/ML software as a medical device (SaMD) action plan in early 2021. Transparency of AI/ML technologies to support of patient-centered approaches was identified as a key goal in the plan report, and publication of the registered AI/ML device list indicates a step toward that goal.

Learn more about US FDA medical device and SaMD regulations at Emergo by UL:

  • FDA 510(k) consulting for medical device and IVD manufacturers
  • Regulatory consulting for telehealth and mobile medical apps
  • Regulatory process chart: FDA registration for medical devices and IVDs



  • Stewart Eisenhart