國內外智慧醫材法規文件
- 21 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 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 The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings, 2022
- 24 (FDA)Good Machine Learning Practice for Medical Device Development Guiding Principles,2021
- 25 (FDA)Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, 2017
- 26 Developing a Software Precertification Program: A Working Model, 2019
- 27 Software Precertification Program: Regulatory Framework for Conducting the Pilot Program within Current Authorities, 2019.
- 28 “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 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 Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions, 2012