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 of Viral Nucleic Acid Tests for Transplants
The FDA has reclassified the quantitative viral nucleic acid test for transplant management into Class II, introducing special controls to ensure safety and effectiveness. This course uncovers the implications of this classification for healthcare providers and manufacturers, highlighting new compliance requirements and their role in facilitating patient access to innovative medical devices.
In this course you will learn the following:
* Understand the classification process and criteria for the quantitative viral nucleic acid test.
* Identify the special controls and general controls applicable to this device.
* Recognize the compliance requirements and deadlines for manufacturers.
* Comprehend the potential risks and mitigation measures associated with the device.
Additional information
| Federal Register Title | Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management. Document Number: 2024-21086 |
|---|---|
| Course SKU | FR-24-221-1 |
| Why This Course Is Important | Without this course, you risk non-compliance with new FDA regulations, which could lead to legal issues and hinder your ability to provide safe and effective transplant care. |