Gain actionable insights into the FDA’s classification of diabetes digital behavioral therapeutic devices as class II (special controls). This course details the regulatory requirements, mandatory special controls, clinical data standards, and labeling obligations. Learn the practical steps manufacturers must take to obtain clearance and ensure ongoing compliance. Discover what’s at stake for device makers, clinical professionals, and regulatory teams under the latest FDA guidance.
In this course you will learn the following:
* Understand the FDA’s classification process for diabetes digital behavioral therapeutic devices.
* Identify the key requirements and special controls now enforceable by law.
* Implement actionable steps to ensure compliance with the new classification and labeling requirements.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
