Discover how the final rule from the CDC expands access to the World Trade Center (WTC) Health Program, now including Pentagon and Shanksville responders. This course unpacks the statutory changes, capped at 500 new enrollees, detailing the impact and compliance with...
FDA Class II Classification: External Compression Device Insights
$9.99
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.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.
Additional information
| Federal Register Title | Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression. Document Number: 2024-19722 |
|---|---|
| Course SKU | FR-24-242-1 |
| Why This Course Is Important | Without this course, you may miss crucial insights into the FDA's classification process, potentially hindering your ability to navigate regulatory requirements and impacting your access to innovative medical devices. |