Course: Proposed Rule on Profits and Related Basis Adjustments based on this document from the Federal Register: https://www.govinfo.gov/content/pkg/FR-2024-12-02/pdf/2024-27227.pdf This document contains proposed regulations regarding previously taxed earnings and...
FDA’s New Classification for Spinal Devices
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.
Additional information
| Federal Register Title | Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device. Document Number: 2024-19726 |
|---|---|
| Course SKU | FR-24-241-1 |
| 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. |