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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 Classification Impact on Hemodialyzer with Enhanced Solute Removal

$9.99

Gain critical insights into the FDA’s classification of the hemodialyzer with expanded solute removal profile into Class II. Discover how special controls enhance safety and effectiveness while improving patient access to cutting-edge medical technology.

In this course you will learn the following:
* Understand the classification process and criteria for medical devices under the FDA.
* Identify the special controls applicable to the hemodialyzer with expanded solute removal profile.
* Recognize the potential risks associated with the device and the mitigation measures required.
* Comprehend the regulatory requirements for compliance and the consequences of non-compliance.

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-24-233-1 Categories: , , , , , Tags: , Course: FDA’s Classification Impact on Hemodialyzer with Enhanced Solute Removal
SKU: FR-24-233-1 Categories: , , , , , Tags: , Course: FDA’s Classification Impact on Hemodialyzer with Enhanced Solute Removal

Why This Course is Important
Without this course, you may lack an understanding of the specific regulatory framework and special controls that ensure the safety and effectiveness of this innovative medical device, potentially compromising patient safety and compliance.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile.

Key regulatory references include:

Course SKU
FR-24-233-1

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