← 所有術語
類別: CLINICAL
獲益-風險評估
系統性評估比較醫療器材的可能獲益與可能風險。FDA和EU MDR均要求所有器材類別的獲益超過殘餘風險。
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
Benefit-risk determination weighs clinical benefits against residual risks and uncertainties. It is central to FDA PMA/De Novo decisions and EU MDR GSPR/clinical evaluation conclusions.
PROCESS / STEPS
- Quantify benefits (clinical outcomes, claims) with appropriate evidence.
- Characterize residual risks after mitigations and probability/severity.
- Address uncertainty, alternatives, and state of the art.
- Document decision logic for regulators and update with PMS data.
EXAMPLES
- A high-risk implant may be favorable if life-saving benefit outweighs known complication rates with informed consent and monitoring.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 獲益-風險評估 across 27 authorities in real time.
START FREE →