FDA issues draft guidance for recommendations on AI devices

The FDA said the guidance aims to develop a regulatory approach to increase patient access to safe and effective medical devices powered by AI and machine learning.

The draft guidance provides recommendations on information to be included in a predetermined change control plan that may be provided in a marketing submission for machine learning-enabled software functions. This includes planned modifications to software functions, the associated methodology to implement and validate modifications, and an assessment of the impact of these modifications.

The FDA said it continues to…