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 New Class II Classification for Coagulation Systems
$9.99
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.
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 Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients. Document Number: 2025-08151 |
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| Course SKU | FR-25-1323-1 |
| Why This Course Is Important | Without this course, you might miss crucial insights into navigating the FDA's regulatory landscape, potentially impacting your ability to innovate and comply with safety standards for coagulation systems. |