按Enter到主內容區
:::
國內外智慧醫材法規文件
-
31
Clinical Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff, 2019
-
32
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.
-
33
General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.
-
34
Policy for Device Software Functions and Mobile Medical Applications, 2019.
-
35
Deciding When To Submit A 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff, 2017
-
36
Computer Software Assurance for Production and Quality System Software, 2022
-
37
Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.
-
38
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff, 2018
-
39
Postmarket Management of Cybersecurity in Medical Devices, 2016
-
40
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, 2014
回頁首