Artificial Intelligence and Machine Learning in Software as a Medical Device: discussion Paper and Request for Feedback

To see the ‘Table of associated records‘ go the bottom, Pag. 2.

A review of the paper for research, educational and recommendations.

Unclassified recommendation

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🔘 Paper page:


FDA (Food and Drug Administration). “Ensure the safety, efficacy, quality and purity of health products by fostering integrity, transparency and excellence; developing and maintaining evidence-based standards and policies, in a healthy and safe work environment.” (Source:, USA.


Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care. The FDA is considering a total product lifecycle-based regulatory framework for these technologies that would allow for modifications to be made from real-world learning and adaptation, while still ensuring that the safety and effectiveness of the software as a medical device is maintained. (Source:


Discussion Paper and Request for Feedback

Please, thank the Publisher

Thank you very much for this work to @US_FDA, via @States_AI_IA #medicaldevices #medicine #machinelearning #rx #research #openscience #openaccess #ai #artificialintelligence #ia #thebibleai #paper

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