Discover how the final rule from the CDC expands access to the World Trade Center (WTC) Health Program, now including Pentagon and Shanksville responders. This course unpacks the statutory changes, capped at 500 new enrollees, detailing the impact and compliance with...
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”.