The FDA has established an Artificial Intelligence Program with a focus on six research topics that delve into the far-reaching implications of medical devices powered by AI and machine learning.

The heart of this effort is how to regulate devices that are designed to continuously evolve and change after they have won regulatory approval, according to the program’s home page.

Initially, the program is focusing on some specific regulatory science gaps and challenges. For example, the agency says there is a lack of methods to analyze the algorithm training and test data upon which the programming is built. There’s also no way to continuously evaluate the safety and effectiveness of these always-changing AI algorithms and their emerging clinical applications — and the FDA says it also lacks a method to monitor AI-powered devices in a postmarketing setting.

Explore the AI Program here.

To read the whole story, click here.

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