US FDA Artificial Intelligence and Machine Learning Discussion Paper

US FDA Artificial Intelligence and Machine Learning Discussion Paper

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

Today, the FDA announced that it is 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 to FDA-2019-N-1185 on regulations.govby June 3, 2019.

Read the Discussion Paper