2020年7月31日，FDA公布2021财年医疗器械评审最新收费情况。

FDAis issuing this guidance to comply with section 702(b)(2) of the FDAReauthorization Act of 2017 (FDARA) (Public Law 115-52), which directs FDA toissue guidance that specifies how the Agency will implement uniform processesand standards that are applicable to inspections (other than for-cause) offoreign and domestic device establishments FDA updated processes and standardsas needed to address the new provisions in section 704(h)(1) of the FederalFood, Drug, and Cosmetic Act (FD&C Act) that were added by FDARA section702(a) and toestablish a standard timeframe for inspections. This guidance alsodescribes standardized methods of communication during the inspection processand identifies practices for investigators and device establishments to facilitatethe continuity of inspections of such establishments.

随着新冠肺炎在美国的爆发，美国健康与人类服务部于2020年1月31日发布了公众健康紧急公告，3月13日，美国总统宣告启动针对新冠肺炎的国家级响应。

近日，美国FDA在其官网发布一则声明称，FDA不会向医疗器械企业颁发注册证书，不会对已经注册或者列名的产品或企业出具 确认证书，企业注册和产品列名信息并不代表FDA批准了该企业和其产品，对于该字样信息，FDA特用标黄进行了提示。

2020年3月13日，欧盟委员会发布（EU）2020/403推荐书，该推荐书被业内誉为新冠肺炎条件下的欧盟绿色通道。一时之间，新冠肺炎防护产品“无需认证直接发货”等说法挤满网站、朋友圈。本文不打算私揣测甚至解读该推荐书的本意，仅将（EU）2020/403推荐书原文呈现，并附中文翻译，以供业内外朋友自度。