Medical Devices; Gastroenterology-Urology Devices; Classification of the Pressure Ulcer Management Tool
Information
Type
Rule
Regulated products
Medical Devices
Published
December 13, 2021
Last updated
December 13, 2021
Description
Document number 2021-26924. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)