Yesterday, the Food and Drug Administration (FDA) announced that it would be taking steps towards considering a new regulatory framework tailored to promote developing safe and effective medical devices that use artificial intelligence algorithms.

The FDA has released a discussion paper to help developers bring AI devices to market through a proposed regulatory framework. The FDA also plans to issue a draft guidance and apply current authorities in new ways to ensure safety of the devices.

“The ability of artificial intelligence and machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices,” FDA Commissioner Scott Gottlieb wrote in a statement.

Gottlieb goes on to say that the goal of the framework is to make sure that “ongoing algorithm changes follow prespecified performance objectives and change control plans, use a validation process that ensures improvements to the performance, safety and effectiveness of the artificial intelligence software, and includes real-world monitoring of performance once the device is on the market to ensure safety and effectiveness are maintained.”

Read More About
Recent
More Topics
About
Jordan Smith
Jordan Smith
Jordan Smith is a MeriTalk Senior Technology Reporter covering the intersection of government and technology.
Tags