FDA 510(k)

2021.09.20

FDA 510(k)申請とは

2019.02.18

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

2019.02.18

Refuse to Accept Policy for 510(k)s

2019.02.18

Guidance for the Content of Premarket Submissions for Software Contained…

2019.01.13

FDA 510(k)申請審査の厳格化とS/Wの信頼性保証について