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Morgan Lewis

How New Executive Orders May Affect FDA’s Medical Device Operations

Morgan Lewis on

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...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

Akin Gump Strauss Hauer & Feld LLP on

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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