Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistRightEye, LLC manufactured the RightEye Vision System, a Class 2 nystagmograph device intended to diagnose visual tracking impairment, but lacked either an approved Premarket Approval (PMA) application or an approved Investigational Device Exemption (IDE) as required by federal law, rendering the device adulterated. The company also violated misbranding requirements under section 502(o) by introducing the device into interstate commerce with major changes or modifications without proper authorization. These violations were identified during an FDA inspection conducted June 28 through July 8, 2022, at the company's Bethesda, Maryland facility, and the company's subsequent responses failed to adequately address the inspectional observations.