Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistWAVi Co. was cited for manufacturing and distributing the WAVi Desktop, a medical device intended to collect, analyze, and interpret data for assessing and diagnosing neurological conditions, without required regulatory approval. The FDA found the device to be adulterated because the company failed to obtain either an approved Premarket Approval (PMA) application or an approved Investigational Device Exemption (IDE) before marketing the product. The violations were identified during an FDA inspection conducted March 23-29, 2023, at the firm's Denver, Colorado facility, and the company's subsequent response in April 2023 was deemed inadequate to address the inspectional observations.