|
11
|
FDA |
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions, 2012
|
|
12
|
FDA |
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Guidance for Industry and Food and Drug Administration Staff, 2019.
|
|
13
|
FDA |
Clinical Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff, 2019
|
|
14
|
FDA |
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.
|
|
15
|
FDA |
General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.
|
|
16
|
FDA |
Policy for Device Software Functions and Mobile Medical Applications, 2019.
|
|
17
|
FDA |
Deciding When To Submit A 510(k) for a Change to an Existing Device - Guidance for Industry and Food and Drug Administration Staff, 2017
|
|
18
|
FDA |
Computer Software Assurance for Production and Quality System Software, 2022
|
|
19
|
FDA |
Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.
|
|
20
|
FDA |
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff, 2018
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