Course: Proposed Rule on Profits and Related Basis Adjustments based on this document from the Federal Register: https://www.govinfo.gov/content/pkg/FR-2024-12-02/pdf/2024-27227.pdf This document contains proposed regulations regarding previously taxed earnings and...
FDA Regulation: Clozapine Test System Classification
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.
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. |