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FDA Classification of Pediatric Renal Therapy Systems

$19.99

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.

NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year.  At the end of the one year term, the course will be set to “inactive”. 

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.

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