Federal Register #FDA-2026-N-7627

FDA Classifies Diabetes Digital Behavioral Therapeutic Device as Class II Medical Device

This notice from the Food and Drug Administration (FDA), Center for Devices and Radiological Health, announces the regulatory classification of a new medical device type: - The diabetes digital behavioral therapeutic device is now classified as a Class II medical device with special controls - Device details: - Prescription-use software that provides digital behavioral therapy to support diabetes management - Intended to offer limited secondary benefit and not to replace primary treatments (e.g., medication, diet, or lifestyle changes) - Not suitable as standalone therapy or for psychiatric disorder treatment - Special controls and requirements include: - Clinical data validation - Software verification and validation - Specific labeling requirements - Risk mitigation measures - No specific OEMs, vendors, or commercial products are named in this regulatory action - This is a regulatory classification, not a procurement or award announcement

Description

The Food and Drug Administration (FDA) is classifying the diabetes digital behavioral therapeutic device into class II with special controls. This device is a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. The classification aims to provide reasonable assurance of safety and effectiveness and to enhance patient access by reducing regulatory burdens. The device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition and is not intended to replace primary treatments such as diet, lifestyle changes, or medication.

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