FDA’s Special Controls for Heparin and Factor Xa Inhibitor Tests

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.