Explore the FDA’s classification of digital therapy devices for ADHD into class II, focusing on special controls for safety and effectiveness. This course covers compliance, implementation strategies, and industry impact, providing invaluable insights for stakeholders in the medical device sector.
In this course you will learn the following:
* Understand the classification process and criteria for the digital therapy device for ADHD.
* Identify the special controls required for compliance.
* Recognize the potential risks and mitigation measures associated with the device.
* Comprehend the consequences of non-compliance with the FDA’s final order.