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CATEGORY: REGULATORY PATHWAYS
Total Product Life Cycle (TPLC)
The FDA approach encompassing all phases of a medical device from conception through design, manufacturing, marketing, use, and disposal. TPLC integrates premarket review with postmarket surveillance for continuous safety monitoring.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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 Total Product Life Cycle (TPLC) across 27 authorities in real time.
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