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 Class II Classification of ADHD Digital Therapy Devices
$9.99
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.
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; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder. Document Number: 2024-19720 |
|---|---|
| Course SKU | FR-24-240-1 |
| Why This Course Is Important | Without this course, you might miss crucial insights into compliance requirements and risk mitigation strategies vital for the successful implementation and use of digital therapy devices for ADHD. |