Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device
Information
Type
Rule
Regulated products
Medical Devices
Published
December 28, 2022
Last updated
December 28, 2022
Description
Document number 2022-28173. The Food and Drug Administration (FDA, Agency or we) is classifying the interventional cardiovascular implant simulation software device 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 interventional cardiovascular implant simulation software device'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)