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 Class II Classification of Voriconazole Test System
$9.99
Dive into the FDA’s decision to classify the voriconazole test system as a Class II device with special controls. This course reveals the impact on safety, effectiveness, and regulatory compliance, ensuring better access to innovative medical devices while maintaining high safety standards. Understand the strategic importance of the De Novo classification process in reducing regulatory burdens and facilitating quicker patient access to essential therapies.
In this course you will learn the following:
* Understand the classification process and criteria for the voriconazole test system.
* Identify the special controls required for compliance.
* Recognize the benefits of the De Novo classification process in reducing regulatory burdens.
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; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System. Document Number: 2025-08148 |
|---|---|
| Course SKU | FR-25-1321-1 |
| Why This Course Is Important | Without this course, learners risk missing crucial insights into FDA's regulatory framework, potentially leading to non-compliance and lost opportunities to leverage reduced regulatory burdens. |