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.