Digital Health Update: Reminder to Submit Comments on the FDA’s Discussion Paper on a Total Product Lifecycle Approach to Regulating Artificial Intelligence and Machine Learning Software as a Medical Device

In April, the FDA announced that it was exploring a framework that would allow for modifications to artificial intelligence and machine learning algorithms 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.

The FDA’s ideas are the foundational first step to developing a total product lifecycle approach to regulating these algorithms that use real-world data to adapt and improve.

Submit comments by June 3