FDA 483 - OxiWear Inc. - July 30, 2025

An FDA inspection of OxiWear Inc. in Buffalo, NY, a medical device manufacturer, identified a significant deficiency in design input documentation. The firm failed to adequately document design input requirements for its OxiWear OxiV3 Ear-Wearable Continuous SpO2 Data Collection System, specifically concerning its intended use across all skin types. This indicates a moderate severity concern regarding the foundational design controls for their medical device.