April 3, 2019

FDA issues statement on review framework for AI-based devices

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration (FDA) on April 2 issued a statement announcing steps toward a new, tailored review framework for artificial intelligence (AI)-based medical devices.

AI and machine learning have the potential to transform the delivery of healthcare, with earlier disease detection, more accurate diagnoses, more targeted therapies, and significant improvement in personalized medicine, the FDA says.

The FDA is exploring a framework that would allow modifications to algorithms from real-world learning and adaptation, while ensuring safety and effectiveness of the software as a medical device is maintained.

As a first step toward a tailored approach to help developers bring AI devices to market, the agency released a discussion paper. Other steps will include a draft guidance that will be informed by the input they receive.

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