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Digital Health Artificial Intelligence Biden Administration

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

Akin Gump Strauss Hauer & Feld LLP

FDA Publishes a Wide Range of Guidances in the Final Days of the Biden Administration

On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and...more

Ropes & Gray LLP

FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical Device Software

Ropes & Gray LLP on

On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - November 2023

Welcome to the November edition of Akin Intelligence. Looking back, October 2023 may be remembered as the month when the U.S. government tried to assume the mantle of global leadership on responsible artificial intelligence...more

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