共 55 条
[2]
[Anonymous], Classify Your Medical Device
[3]
[Anonymous], 2023, Marketing submission recommendations for a predetermined change control plan for artificial intelligence/machine learning (AI/ ML)-enabled device software functions
[4]
[Anonymous], 2024, Regulation (EU) 2024/1347 of the European Parliament and of the Council
[5]
[Anonymous], Clinical Decision Support Software: Draft Guidance for Industry and Food and Drug Administration Staff
[6]
[Anonymous], 1954, Federal Food, Drug, and Cosmetic Act Amendments
[7]
[Anonymous], 2019, Overview of device regulation
[8]
AI Integration in the Clinical Workflow
[J].
JOURNAL OF DIGITAL IMAGING,
2021, 34 (06)
:1435-1446