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The U.S. Food and Drug Administration’s (FDA) recently released discussion paper on generative artificial intelligence (GenAI)-enabled medical devices may be as notable for what it does not say as what it does say.

Over the last decade, investigation timelines for transactions subject to Second Requests soared. Before 2015, the average timelines for Second Request investigation regularly fell under eight months. By 2025, that average had climbed to over 12 months. Of course, these average timelines only cover time before the agency decides whether to challenge a transaction. For transactions subject to a complaint, the clock ran longer. And as dealmakers know, time is often the enemy of closing.

On August 26, 2026, President Trump issued Executive Order 14420, “Declaring a National Emergency to Secure the United States Bulk-Power System,” which declares a national emergency under the International Emergency Economic Powers Act (IEEPA) and the National Emergencies Act (NEA), and authorizes the U.S.