The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] 2019.02.18 The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Tweet Share Hatena Pocket RSS feedly Pin it FDA 510(k)関連 レビュと承認について 内部監査について 関連記事一覧 Guidance for the Content of Premarket Submissions f... 2019.02.18 FDA 510(k)申請とは 2021.09.20 Refuse to Accept Policy for 510(k)s 2019.02.18 FDA 510(k)申請審査の厳格化とS/Wの信頼性保証について 2019.01.13