Discover how the final rule from the CDC expands access to the World Trade Center (WTC) Health Program, now including Pentagon and Shanksville responders. This course unpacks the statutory changes, capped at 500 new enrollees, detailing the impact and compliance with...
FDA’s Classification Impact on Hemodialyzer with Enhanced Solute Removal
$9.99
Gain critical insights into the FDA’s classification of the hemodialyzer with expanded solute removal profile into Class II. Discover how special controls enhance safety and effectiveness while improving patient access to cutting-edge medical technology.
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 hemodialyzer with expanded solute removal profile.
* Recognize the potential risks associated with the device and the mitigation measures required.
* Comprehend the regulatory requirements for compliance and the consequences of non-compliance.
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; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile. Document Number: 2024-20081 |
|---|---|
| Course SKU | FR-24-233-1 |
| Why This Course Is Important | Without this course, you may lack an understanding of the specific regulatory framework and special controls that ensure the safety and effectiveness of this innovative medical device, potentially compromising patient safety and compliance. |