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Software Warning Letters

Sheppard Mullin Richter & Hampton LLP

FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices

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 and associated...more

King & Spalding

The Federal Trade Commission Issues Warning Letters To App Developers

King & Spalding on

On March 17, 2016, the Federal Trade Commission (“FTC”) announced it had issued warning letters to twelve application (“app”) developers who installed in their apps software created by the company SilverPush that is capable...more

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