$19.99
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.
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”.
Why This Course is Important
Without this course, manufacturers and stakeholders risk failing to meet FDA requirements, resulting in delayed market entry, enforcement actions, or lost access for patients to innovative diabetes management tools.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device.
Key regulatory references include:
Course SKU
FR-26-2105-1
CourseAvenue eLearning Platform has helped Federal agencies (and their suppliers) successfully address their most complex eLearning accessibility challenges.
Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026. Document Number: 2026-21420
Buy this Course
FR-26-3274-1
Why This Course is Important
Without this training, you risk misunderstanding significant regulatory changes, missing compliance deadlines, and failing to leverage opportunities for public comment or operational adaptation—potentially resulting in penalties or loss of competitive advantage.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026.
Key regulatory references include:
Course SKU
FR-26-3274-1
© 2026 CourseAvenue, LLC | All rights reserved.
