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FDA Maintains Focus On "Intended Use" For Software-Enabled Medical Devices

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

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FDA Maintains Focus on "Intended Use" for Software-Enabled Medical Devices | Sheppard Mullin Richter & Hampton LLP

FDA Maintains Focus on "Intended Use" for Software-Enabled Medical Devices | Sheppard Mullin Richter & Hampton LLP
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FDA Issues Warning Letter to Zyto Technologies Inc

FDA Issues Warning Letter to Zyto Technologies Inc
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