CDRH Issues Warning Letter Over Off-label Promotion

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CDRH Issues Warning Letter Over Off-label Promotion

J.W. Schomisch

February 22, 2023 at 10:43 AM EST

The Center for Devices and Radiological Health (CDRH) sent a Warning Letter to the manufacturer for off-label promotion of a vision system. The Warning Letter to RightEye, LLC, Bethesda, Md., alleged the company’s promotion of its RightEye Vision System “provides evidence that the device is intended to improve vision problems and measure and analyze eye movements for the broa... Read More

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CDRH Issues Warning Letter Over Off-label Promotion

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