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類別: CLASSIFICATION
數位健康
涵蓋行動健康應用、健康IT、遠程醫療、穿戴式裝置和SaMD的廣泛類別。FDA數位健康卓越中心（DHCoE）監管數位健康技術的法規框架。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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 數位健康 across 27 authorities in real time.
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