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...
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FDA’s Special Controls for Heparin and Factor Xa Inhibitor Tests
This course sheds light on the FDA’s recent ruling, placing the heparin and direct oral factor Xa inhibitor drug test system into class II. Learn the special controls designed to ensure safety and performance while enhancing patient access to cutting-edge medical technologies.
In this course you will learn the following:
* Understand the classification process and criteria for medical devices under the FDA.
* Identify the special controls applicable to the heparin and direct oral factor Xa inhibitor drug test system.
* Recognize the significance of the De Novo classification process and its impact on device marketing.
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Additional information
| Federal Register Title | Medical Devices; Hematology and Pathology Devices; Classification of the Heparin and Direct Oral Factor Xa Inhibitor Drug Test System. Document Number: 2024-19824 |
|---|---|
| Course SKU | FR-24-234-1 |
| Why This Course Is Important | Without this course, you might miss out on understanding critical safety measures and regulatory requirements that affect patient care and market access for hematology devices. |