Medical Devices; Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions
Information
Type
Rule
Regulated products
Medical Devices
Published
November 9, 2023
Last updated
November 9, 2023
Description
Document number 2023-24717. The Food and Drug Administration (FDA, Agency, or we) is classifying the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions. We are taking this action because we have determined that classifying the device into class II (special controls) 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)