FDA Regulation: A Peek into AI Proposed Regulatory Framework

Artificial intelligence applications rely on diverse datasets to make informed decisions. As datasets grow, algorithms improve in sensitivity and specificity. The challenge remains, how to handle this from a regulatory perspective without hindering innovation and delaying products into the market?

The FDA is considering modifications to the Software as a Medical Device Pre-Specifications (SaMD) that would allow for changes to be made because of learning and adaptation. The FDA’s goal is to ensure that the safety and effectiveness of the software as a medical device is maintained.

In this discussion, Shawnnah will lead an overview of the Software as a Medical Device Pre-Specifications (SaMD) guidance(s) and how the proposed FDA framework allows for iterative improvements of artificial intelligence and machine learning-based software as a medical device, while assuring patient safety.