|
21
|
TFDA |
適用於製造業者之醫療器材網路安全指引(發布日期：2021年5月4日)
|
|
22
|
TFDA |
人工智慧/機器學習技術之電腦輔助分流(Computer Aided Triage)醫療器材軟體查驗登記技術指引(發布日期：2022年2月14日)
|
|
23
|
FDA |
The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings, 2022
|
|
24
|
FDA |
(FDA)Good Machine Learning Practice for Medical Device Development Guiding Principles,2021
|
|
25
|
FDA |
(FDA)Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, 2017
|
|
26
|
FDA |
Developing a Software Precertification Program: A Working Model, 2019
|
|
27
|
FDA |
Software Precertification Program: Regulatory Framework for Conducting the Pilot Program within Current Authorities, 2019.
|
|
28
|
FDA |
“Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD)-Discussion Paper and Request for Feedback”, 2019.
|
|
29
|
FDA |
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions, 2020
|
|
30
|
FDA |
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions, 2012
|
