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 Classification of Pediatric Renal Therapy Systems
This course provides a comprehensive overview of the FDA’s classification of pediatric continuous renal replacement therapy systems as class II devices with special controls. It focuses on safety, effectiveness, and compliance requirements crucial for manufacturers and healthcare providers. Gain insights into the regulatory framework that enhances patient access to innovative renal therapy devices.
In this course you will learn the following:
* Understand the classification process and criteria for the pediatric continuous renal replacement therapy system.
* 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; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System. Document Number: 2024-20999 |
|---|---|
| Course SKU | FR-24-225-1 |
| Why This Course Is Important | Without this course, learners may lack critical knowledge of FDA's special controls necessary for compliance, risking regulatory non-compliance and potential patient safety issues. |