Medical Devices; General Hospital and Personal Use Devices; Classification of the Alternate Controller Enabled Infusion Pump
Information
Type
Rule
Regulated products
Medical Devices
Published
February 4, 2022
Last updated
February 4, 2022
Description
Document number 2022-02369. The Food and Drug Administration (FDA, Agency, or we) is classifying the alternate controller enabled infusion pump 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 alternate controller enabled infusion pump's classification. 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)