Discover how the FDA’s new classification impacts the safety and effectiveness of spinal devices. This course provides critical insights into the specific requirements and benefits of the Class II classification, including special controls designed to enhance patient safety and access to cutting-edge innovations.
In this course you will learn the following:
* Understand the classification process and criteria for the intervertebral body graft containment device.
* Identify the special controls required for compliance with the new classification.
* Recognize the impact of this classification on device sponsors and patient access.