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类别: CLASSIFICATION
数字健康
涵盖移动健康应用、健康IT、远程医疗、可穿戴设备和SaMD的广泛类别。FDA数字健康卓越中心（DHCoE）监管数字健康技术的法规框架。
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 数字健康 across 27 authorities in real time.
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