FDA finalizes recommendations simplifying approval process for medical devices that use AI

The Food and Drug Administration yesterday released recommendations for streamlining the approval process for medical devices that use artificial intelligence. The guidance recommends information to include in a predetermined change control plan as part of a marketing submission for a medical device using AI. The PCCP should include a description of the device's planned modifications; methods to develop, validate and implement the modifications; and an assessment of the modification's impacts. FDA will then review the PCCP within the submission to ensure the device's safety and effectiveness without needing additional marketing submissions for each modification.