The Food and Drug Administration (FDA) is considering a total product lifecycle-based regulatory framework for AI/ML technologies that would allow for modifications to be made from real-world learning and adaptation, while still ensuring that the safety and effectiveness of the software as a medical device is maintained.
Name in original language
Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device
Initiative overview
The FDA's traditional paradigm of medical device regulation was not designed for adaptive AI and ML technologies. Under the FDA's current approach to software modifications, the FDA anticipates that many of these AI and ML-driven software changes to a device may need a pre-market review.The initiative has the following objective(s):To seek public comment on a discussion paper that describes the FDA's foundation for a potential approach to pre-market review for AI/ML-driven software modifications.
Name of responsible organisation (in English)
Food and Drug Administration (FDA)
