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 Regulation: Clozapine Test System Classification
$9.99
Gain insight into the FDA’s latest rule on classifying the clozapine test system under Class II with special controls. This course will guide you through the safety, effectiveness, and regulatory requirements impacting healthcare providers and device sponsors, ensuring compliance and enhancing patient access to cutting-edge medical technology.
In this course you will learn the following:
* Understand the classification process and criteria for the clozapine test system.
* Identify the special controls required for compliance.
* Recognize the impact of this classification on device sponsors 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; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System. Document Number: 2024-20895 |
|---|---|
| Course SKU | FR-24-223-1 |
| Why This Course Is Important | Without this course, healthcare professionals and device sponsors may struggle to comply with FDA regulations, risking non-compliance and delayed market access for the clozapine test system. |