美國食品藥品管理局（FDA）于2017年1月發(fā)布了"符合FDA核準(zhǔn)的說明書的醫(yī)療產(chǎn)品的交流信息——問答供企業(yè)用指導(dǎo)原則"，該指導(dǎo)原則介紹了FDA判斷公司提出的有關(guān)產(chǎn)品應(yīng)用的交流信息是否符合說明書（即是否在說明書允許的范圍內(nèi)）的基本原則并列舉了實(shí)例。介紹該指導(dǎo)原則的主要內(nèi)容，并期望對(duì)我國醫(yī)療產(chǎn)品交流信息的規(guī)范化及其監(jiān)管有益。

FDA issued Medical Product Communications That Are Consistent With FDA-Required Labeling-Questions and Answers Guidance for Industry in January 2017, which introduced basic principles on which FDA to determine whether firms' medical product communications about the use of the product are consistent with the FDA-required labeling (i.e. whether in the allowable range of labeling) and listed examples. This paper introduces the guidance, and is expected to be beneficial to the standardization and supervision of the medical product communications in China.