FDA classifies diabetes digital behavioral therapeutic devices as Class II
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Table of Contents
The Food and Drug Administration (FDA) has issued a final rule classifying a new category of medical tools called “diabetes digital behavioral therapeutic devices.” These are digital tools—likely apps or software—designed to help people manage their diabetes through behavior changes.
Why it matters: This is an administrative move that establishes the rules for a specific type of digital health tool. It provides a predictable regulatory path for developers of diabetes management software.
Who it affects
- Software developers and medical device companies creating diabetes management tools
This action was taken by the FDA as published in the Federal Register; readers should consult the official document before relying on this information for regulatory compliance.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document