Artificial Intelligence Medical Devices

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fda.gov
https://www.fda.gov › medical-devices › software-medical-device-samd …
Transparency for Machine Learning-Enabled Medical Devices
Jun 13, 2024 · GMLP supports the development of safe, effective and high-quality artificial intelligence/machine learning technologies that can learn from real-world use and, in some cases, improve device ...
fda.gov
https://www.fda.gov › ... › fda-releases-artificial-intelligencemachine-lear…
FDA Releases Artificial Intelligence/Machine Learning Action Plan
FDA has released the Artificial Intelligence/Machine Learning- Based Software as a Medical Device Action Plan which outlines FDA’s next steps towards advancing practical oversight for these issues.
fda.gov
https://www.fda.gov › media › download
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Artificial Intelligence and Machine Learning in Medical Devices
May 9, 2022 · ML-Enabled Medical Device (MLMD): A medical device that uses machine learning, in part or in whole, to achieve its intended medical purpose.
fda.gov
https://www.fda.gov › medical-devices › software-medical-device-samd …
Good Machine Learning Practice for Medical Device Development
These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).
fda.gov
https://www.fda.gov › medical-devices › digital-health-center-excellence …
Software as a Medical Device (SaMD) - FDA
Your Clinical Decision Support Software: Is It a Medical Device? Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
fda.gov
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Artificial Intelligence (AI) and Machine Learning (ML) in …
Oct 22, 2020 · 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.
fda.gov
https://www.fda.gov › news-events › fda-voices › fda-releases-two-discu…
FDA Releases Two Discussion Papers to Spur Conversation about ...
To address these concerns, the FDA has released a discussion paper, “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products.”
fda.gov
https://www.fda.gov › media › download
[PDF]
Artificial Intelligence/Machine Learning (AI/ML)-Based.:Jf/<X …
Artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during ...
fda.gov
https://www.fda.gov › medical-devices › medical-device-regulatory-scien…
Postmarket Monitoring of AI-Enabled Medical Devices
Jun 10, 2024 · Tools that detect changes to the inputs of AI-enabled medical devices, monitor the performance of their outputs, and understand the causes of performance variations aid in quality assurance ...
fda.gov
https://www.fda.gov › regulatory-information › search-fda-guidance-docu…
Predetermined Change Control Plan for Artificial Intelligence …
Dec 3, 2024 · FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices.
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