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Home » RightEye Slapped with FDA Warning Letter for Lack of Premarket Approval
RightEye Slapped with FDA Warning Letter for Lack of Premarket Approval
Bethesda, Md.-based RightEye, manufacturer of the RightEye Vision System, has received a warning letter from the FDA for marketing its device without a premarket approval application for new indications, failure to maintain written design control procedures and other serious lapses.