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

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This report discusses a proposed framework for modifications to AI/ML-based SaMD that is based on the internally harmonized International Medical Device Regulators Forum risk categorization principles, FDA's benfit-risk framework, risk management principles in the software modifications guidance, and the organization-based TPLC approach as envisioned in the Digital health Software Precertification Program. The authors ask for public feedback about the questions posed in the report.

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20 p.

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United States. Food and Drug Administration. January 2021.

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This report is part of the collection entitled: Artificial Intelligence (AI) Policy Collection and was provided by the UNT Libraries Government Documents Department to the UNT Digital Library, a digital repository hosted by the UNT Libraries. More information about this report can be viewed below.

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Description

This report discusses a proposed framework for modifications to AI/ML-based SaMD that is based on the internally harmonized International Medical Device Regulators Forum risk categorization principles, FDA's benfit-risk framework, risk management principles in the software modifications guidance, and the organization-based TPLC approach as envisioned in the Digital health Software Precertification Program. The authors ask for public feedback about the questions posed in the report.

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20 p.

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Artificial Intelligence (AI) Policy Collection

The Artificial Intelligence (AI) Policy Collection contains open access resources that provide policy overviews, implementation plans, guiding frameworks, and resources for implementing artificial intelligence and machine learning in a wide range of environments. This collection includes documents published by Federal agencies, non-governmental organizations, international, state, and local governments.

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  • January 2021

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  • March 6, 2024, 5:46 a.m.

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  • May 15, 2024, 10:05 a.m.

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Thumbnail image of item number 1 in: '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'.
Thumbnail image of item number 2 in: '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'.
Thumbnail image of item number 3 in: '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'.
Thumbnail image of item number 4 in: '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'.

PDF Version Also Available for Download.

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United States. Food and Drug Administration. 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, report, January 2021; (https://digital.library.unt.edu/ark:/67531/metadc2289515/: accessed June 4, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.

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