美國(guó)食品藥品管理局（FDA）的“供企業(yè)用藥-械和生物制品-器械組合產(chǎn)品的橋接指導(dǎo)原則（草案）”詳細(xì)描述了藥-械組合產(chǎn)品注冊(cè)申請(qǐng)人，利用另外的開(kāi)發(fā)方案產(chǎn)生的信息，作為擬開(kāi)發(fā)產(chǎn)品的注冊(cè)資料（即橋接），替代試驗(yàn)研究資料的方法，支持?jǐn)M申報(bào)產(chǎn)品的批準(zhǔn)；推薦漸進(jìn)式5步驟法，確定橋接策略和信息需求并列舉了3個(gè)示例予以解讀。詳細(xì)介紹該指導(dǎo)原則的內(nèi)容，期望為中國(guó)藥-械組合產(chǎn)品研發(fā)和監(jiān)管開(kāi)辟新思路，建議在合適的條件下可考慮利用“橋接”方法減少試驗(yàn)研究，加速研究進(jìn)程，縮短研究周期，節(jié)省研究經(jīng)費(fèi)，促進(jìn)藥-械組合產(chǎn)品的開(kāi)發(fā)。

The FDA's Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry (Draft) described in detail that the applicant for registration of drug-device combination products can use the information developed by another development program as the registration information of the product to be developed (i. e. bridging) and replace the experimental research data to support the approval of the product to be applied for. That is to say, the stepwise five step approach is recommended to determine the bridging strategy and information requirements are determined, and three examples are given to interpret. This paper introduces the guidance in detail, hoping to open up new ideas for the research and development as well as supervision of drug-device combination products in China. In suitable conditions, it can be considered to use "bridging" method to reduce experimental research, speed up the research process, shorten the research cycle, save research funds, and promote the development of drug-device combination products.

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