Explore the FDA’s transformative ruling on the classification of coagulation systems used for whole blood viscoelastic properties in perioperative patients. This course unpacks the intricacies of Class II classification, ensuring device safety and effectiveness through special controls. Learn how these regulations pave the way for innovation by reducing regulatory hurdles, ultimately enhancing patient care and access to cutting-edge medical devices.
In this course you will learn the following:
* Understand the purpose and scope of the FDA’s classification of coagulation systems.
* Identify the key requirements and special controls associated with class II classification.
* Recognize the implications for device manufacturers and healthcare providers.
