FDA Is Developing Rules for AI-based Medical Devices

Artificial intelligence and machine learning could radically change how health care is delivered and the Federal Drug Commission is now taking steps to consider a regulatory framework for AI devices that continually adapt based on new data.

In an announcement yesterday, FDA Commissioner Scott Gottlieb said the agency is releasing a discussion paper with the goal of helping developers bring AI devices to market. After FDA receives input on the framework, it will issue a draft guidance based on the feedback. 

“Our approach will focus on the continually-evolving nature of these promising technologies,” Gottlieb said. “We plan to apply our current authorities in new ways to keep up with the rapid pace of innovation and ensure the safety of these devices.”

The framework would address the need for algorithms to learn and adapt in the real world, a manufacturer’s plans to make modifications to the algorithms and how to manage the risk associated with any modifications. 

“A new approach to these technologies would address the need for the algorithms to learn and adapt when used in the real world,” Gottlieb said in a statement. “It would be a more tailored fit than our existing regulatory paradigm for software as a medical device.”