FDA Announces Framework for Medical Devices Using AI

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 The FDA also plans to issue a draft guidance and apply current authorities in new ways to ensure safety of the devices.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.”

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