Artificial intelligence and machine learning have the potential to fundamentally transform the delivery of health care. As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies and significant improvements in personalized medicine.

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.

Today, we’re announcing steps to consider a new regulatory framework specifically tailored to promote the development of safe and effective medical devices that use advanced artificial intelligence algorithms.
Artificial intelligence algorithms are software that can learn from and act on data. These types of algorithms are already being used to aid in screening for diseases and to provide treatment recommendations. Last year, the FDA authorized an artificial intelligence based device for detecting diabetic retinopathy, an eye disease that can cause vision loss. The agency also authorized a second artificial intelligence based device for alerting providers of a potential stroke in patients.

The authorization of these technologies was a harbinger of progress that the FDA expects to see as more medical devices incorporate advanced artificial intelligence algorithms to improve their performance and safety. Artificial intelligence has helped transform industries like finance and manufacturing, and I’m confident that these technologies will have a profound and positive impact on health care. I can envision a world where, one day, artificial intelligence can help detect and treat challenging health problems, for example by recognizing the signs of disease well in advance of what we can do today. These tools can provide more time for intervention, identifying effective therapies and ultimately saving lives.

We’re taking the first step toward developing a novel and tailored approach to help developers bring artificial intelligence devices to market by releasing a discussion paper. Other steps in the future will include issuing draft guidance that will be informed by the input we receive. Our approach will focus on the continually-evolving nature of these promising technologies. 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.

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