This course offers a comprehensive analysis of the FDA’s classification of the neuromuscular tongue muscle stimulator into class II with special controls. Learn about the specific regulatory requirements, how these changes impact device manufacturers, and what healthcare providers need to know to ensure compliance and patient safety.
In this course you will learn the following:
* Understand the classification process and criteria for the neuromuscular tongue muscle stimulator.
* Identify the special controls and general controls applicable to the device.
* Recognize the compliance requirements and deadlines for manufacturers.
* Understand the potential consequences of non-compliance with the FDA’s final rule.