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类别: REGULATORY PATHWAYS
全产品生命周期(TPLC)
FDA方法涵盖医疗器械从构思、设计、制造、销售、使用到处置的所有阶段。TPLC将上市前审查与上市后监管整合，实现持续安全监控。
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
Total product lifecycle (TPLC) is FDA’s framing that connects premarket review, manufacturing quality, and postmarket surveillance into one continuous safety/effectiveness story—especially visible in digital health and high-risk devices.
PROCESS / STEPS
- Plan premarket evidence with postmarket commitments in mind.
- Use real-world performance to refine risk controls and labeling.
- Feed complaints, MDRs, and recalls into design changes.
- Align cybersecurity and software updates with lifecycle risk management.
EXAMPLES
- AI device predetermined change control plans embody TPLC thinking for iterative model updates.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 全产品生命周期(TPLC) across 27 authorities in real time.
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