Course: Proposed Rule on Profits and Related Basis Adjustments based on this document from the Federal Register: https://www.govinfo.gov/content/pkg/FR-2024-12-02/pdf/2024-27227.pdf This document contains proposed regulations regarding previously taxed earnings and...
FDA’s Class II Classification of ADHD Digital Therapy Devices
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.
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. |