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