FDA Class II Classification: External Compression Device Insights

Dive into the FDA’s pivotal ruling that classifies the external compression device for internal jugular vein compression into class II, accompanied by special controls. This course unpacks the regulatory landscape, exploring how this classification enhances safety and effectiveness, while expanding market access for innovative medical devices.

In this course you will learn the following:
* Understand the classification process and criteria for medical devices.
* Identify the special controls applicable to the external compression device.
* Recognize the implications of class II classification for device manufacturers and users.