Gain a comprehensive understanding of the FDA’s classification of radiological computer-assisted detection and diagnosis software into class II. Explore the special controls established to ensure safety and effectiveness, and learn how these regulations impact patient access to innovative devices.
In this course you will learn the following:
* Understand the classification of radiological computer-assisted detection and diagnosis software into class II.
* Identify the special controls required for compliance.
* Recognize the impact of this classification on regulatory processes and patient access to innovative devices.


