United States: FDA Maintains Focus On "Intended Use" For Software-Enabled Medical Devices - Sheppard Mullin Richter & Hampton

On June 21, 2023, the U.S. Food and Drug Administration ("FDA") issued a warning letter to Zyto Technologies, Inc. ("Zyto"), citing Zyto's promotion of its Hand Cradle Galvanic Skin Response ("GSR") device...