美国FDA《临床研究监督–基于风险的监管方法》指导原则研究及其对我国的启示

Research and Influence in China of the Guidance for Industry Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring

美国食品药品监督管理局(FDA)发布的《临床研究监督-基于风险的监管方法》中对医疗器械临床研究采取基于风险的监管制度,监管方法主要有现场监管和集中监管两类,监管流程主要包括确定待监管的关键数据和过程、风险评估和制定监管计划。文章采用文献分析法,以《临床研究监督-基于风险的监管方法》内容为主线,重点分析该指南针对医疗器械临床研究监督管理的相关政策和法规的指导,尝试分析FDA对医疗器械临床研究监管的立法思路,为我国医疗器械临床研究监管制度的建立和完善提供参考和借鉴。

FDA published the Guidance for Industry Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring. It adopts a risk-based supervision system for clinical research of medical devices. The main methods of supervision are on-site supervision and centralized supervision. The supervision process mainly includes identifying key data and processes to be supervised, risk assessment and formulation of supervision plans. The content of Guidance for Industry of Clinical Investigations-A Risk-Based Approach to Monitoring was analyzed as the main line by literature analysis method, focusing on the analysis of relevant policies and regulations for medical device clinical research supervision and management, and attempted to analyze the FDA？s legislative thinking on the clinical research supervision of medical devices. Provides reference for the establishment and improvement of medical device clinical research supervision system.