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1
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FDA |
Clinical Decision Support Software, 2022
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2
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FDA |
(FDA)Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, 2017
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3
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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
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4
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FDA |
Postmarket Management of Cybersecurity in Medical Devices, 2016
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5
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FDA |
The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings, 2022
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6
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FDA |
(FDA)Good Machine Learning Practice for Medical Device Development Guiding Principles,2021
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7
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FDA |
Developing a Software Precertification Program: A Working Model, 2019
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8
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FDA |
Software Precertification Program: Regulatory Framework for Conducting the Pilot Program within Current Authorities, 2019.
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9
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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.
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10
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FDA |
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions, 2012
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