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The course you are looking at is not like any other e-Learning course you have ever taken. Watch this short video to learn why!

FDA’s New Classification of Viral Nucleic Acid Tests for Transplants

$9.99

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.

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”. 

SKU: FR-24-221-1 Categories: , , , , Tags: , Course: FDA’s New Classification of Viral Nucleic Acid Tests for Transplants
SKU: FR-24-221-1 Categories: , , , , Tags: , Course: FDA’s New Classification of Viral Nucleic Acid Tests for Transplants

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.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management.

Key regulatory references include:

Course SKU
FR-24-221-1

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