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FDA’s New Classification for Spinal Devices

$9.99

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.

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”. 

Why This Course is Important
By not enrolling in this course, you risk missing key insights into regulatory changes that could affect your role in device manufacturing, compliance, or distribution.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device.

Key regulatory references include:

Course SKU
FR-24-241-1