Re: AI/ML-Assisted SaMD

Thanks a million for sharing this important info about SaMD.

Please all check out:
Artificial Intelligence and Machine Learning in Software as a Medical Device

  
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Artificial Intelligence and Machine Learning in Software as a Medical Device
 By Center for Devices and Radiological Health   |  |

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for the future of the single most important use of AI  Milton Ponson
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Project Paradigm: Bringing the ICT tools for sustainable development to all stakeholders worldwide through collaborative research on applied mathematics, advanced modeling, software and standards development 

    On Monday, April 8, 2019 1:19 PM, "owen.ambur@verizon.net" <owen.ambur@verizon.net> wrote:
 

 The content of FDA's request for comments on its proposed regulatory framework for modifications to artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) and proposed content for an algorithm change protocol are now available in StratML format at http://stratml.us/drybridge/index.htm#FDA
Here's the comment I submitted:

Consistent with the good practice set forth in section 10 of the GPRA Modernization Act (GPRAMA) and the new OPEN Government Data Act (OGDA), plans and performance reports for AI/ML-based SaMD should be published in an open, standard, machine-readable format like StratML Part 2, Performance Plans and Reports. https://www.linkedin.com/pulse/open-machine-readable-government-owen-ambur/ | http://stratml.us/references/HR4174.htm#Title_II | http://stratml.us/#Part2

Owen