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類別: REGULATORY PATHWAYS
全產品生命週期(TPLC)
FDA方法涵蓋醫療器材從構思、設計、製造、銷售、使用到處置的所有階段。TPLC將上市前審查與上市後監管整合，實現持續安全監控。
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 全產品生命週期(TPLC) across 27 authorities in real time.
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