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Data Management › Transparency › Medical Devices

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

Ropes & Gray LLP on

In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

Orrick, Herrington & Sutcliffe LLP

FDA Issues Draft Guidance on AI-Enabled Medical Devices

Orrick, Herrington & Sutcliffe LLP on

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

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