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Why buy this course?

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 Special Controls for Heparin and Factor Xa Inhibitor Tests

$9.99

This course sheds light on the FDA’s recent ruling, placing the heparin and direct oral factor Xa inhibitor drug test system into class II. Learn the special controls designed to ensure safety and performance while enhancing patient access to cutting-edge medical technologies.

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 heparin and direct oral factor Xa inhibitor drug test system.
* Recognize the significance of the De Novo classification process and its impact on device marketing.

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”. 

Additional information

Federal Register Title

Medical Devices; Hematology and Pathology Devices; Classification of the Heparin and Direct Oral Factor Xa Inhibitor Drug Test System. Document Number: 2024-19824

Course SKU

FR-24-234-1

Why This Course Is Important

Without this course, you might miss out on understanding critical safety measures and regulatory requirements that affect patient care and market access for hematology devices.

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