文件名称：Deciding-When-to-Submit-a-510(k)-for-a-Software-Change-to-an-Existing-Device.pdf
文件大小：585KB
文件格式：PDF
更新时间：2023-04-25 00:02:06
FDA 510K SOFTWARE
Deciding When to Submit a 510(k) for a Software Change to an Existing Device ______________________________________________________________________________ Guidance for Industry and Food and Drug Administration Staff Document issued on October 25, 2017. The draft of this document was issued on August 8, 2016.