Final Guidances on Deciding When to Submit a 510(k) for a Change to an Existing

[视频作者] 好大的虎纹砂鱼

[视频时长] 86:50

[视频类型] 科学科普

https://www.youtube.com/watch_popup?v=X_4v2UpBVbw On October 25, 2017 the FDA released two final guidance documents: Deciding When to Submit a 510(k) for a Change to an Existing Device, which defines the medical device changes broadly, and Deciding When t