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CATEGORY: CLASSIFICATION
Digital Health
The broad category encompassing mobile health apps, health IT, telemedicine, wearables, and SaMD. FDA's Digital Health Center of Excellence (DHCoE) oversees the regulatory framework for digital health technologies.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Digital health spans SaMD, connected devices, telehealth tools, and AI/ML—regulated when medical claims and patient risk meet device definitions.
PROCESS / STEPS
- Determine if the software/device is regulated.
- Apply software lifecycle, cybersecurity, and clinical validation.
- Select premarket path; plan change control for algorithm updates.
- Monitor postmarket performance and safety signals.
EXAMPLES
- Wellness apps without medical claims may fall outside device regulation; diagnostic claims usually do not.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Digital Health across 27 authorities in real time.
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