|
31
|
FDA |
Clinical Decision Support Software, 2022
|
|
32
|
FDA |
(FDA)Proposed Regulatory Framework for Modifications to Artificial Intelligence Machine Learning-Based Software as a Medical Device (SaMD), 2021
|
|
33
|
FDA |
Software as a Medical Device (SAMD): Clinical Evaluation, 2017
|
|
34
|
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.
|
|
35
|
FDA |
Clinical Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff, 2019
|
|
36
|
FDA |
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.
|
|
37
|
FDA |
General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff, 2019.
|
|
38
|
FDA |
Policy for Device Software Functions and Mobile Medical Applications, 2019.
|
|
39
|
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
|
|
40
|
FDA |
Computer Software Assurance for Production and Quality System Software, 2022
|
