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 Rule on Class II Medical Devices: Open Loop Fluid Therapy
The course offers detailed insights into the FDA’s classification of the adjunctive open loop fluid therapy recommender as a class II medical device. Discover the special controls required for compliance, including clinical performance testing and software verification, ensuring the device’s safe and effective integration into healthcare practices. Enhance your understanding of the regulatory framework that governs innovative medical technologies.
In this course you will learn the following:
* Understand the classification process and criteria for the adjunctive open loop fluid therapy recommender.
* Identify the special controls required for compliance.
* Recognize the potential risks and mitigation measures associated with the device.
Additional information
| Federal Register Title | Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender. Document Number: 2024-19736 |
|---|---|
| Course SKU | FR-24-235-1 |
| Why This Course Is Important | Without this course, learners may miss out on understanding the critical compliance requirements and risk mitigation strategies necessary for the safe and effective use of the open loop fluid therapy recommender. |