Medical Devices; Gastroenterology-Urology Devices; Classification of the Pressure Ulcer Management Tool

摘要

The Food and Drug Administration (FDA or we) is classifying the pressure ulcer management tool into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.