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1. www.fda.gov › medical-devices › software-medicalGood Machine Learning Practice for Medical Device Development

   www.fda.gov › medical-devices › software-medical

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   The identified guiding principles can inform the development of good machine learning practices to promote safe, effective, and high-quality medical devices. ... (FDA), Health Canada, and the ...

   • FDA Releases Artificial Intelligence/Machine Learning Action ...

     For Immediate Release: January 12, 2021. Today, the U.S....

   • Artificial Intelligence and Machine Learning in Software

     On April 2, 2019, the FDA published a discussion paper...

   • Artificial Intelligence and Machine Learning (AI/ML)-Enabled ...

     The FDA has updated the list of AI/ML-enabled medical...

   • FDA In Brief: FDA Collaborates with Health Canada and UK’s ...

     Today, FDA, Health Canada and the UK’s MHRA jointly issued...

2. www.fda.gov › media › 153486Good Machine Learning Practice for Medical Device Development ...

   www.fda.gov › media › 153486

   Good Machine Learning Practice for Medical Device Development: Guiding Principles . October 2021 . The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and

3. People also ask

   What is good machine learning practice?

   • Good Machine Learning Practice is intended to advance high quality artificial intelligence/machine learning enabled medical device development.

   FDA In Brief: FDA Collaborates with Health Canada and UK’s MHRA to

   www.fda.gov/news-events/press-announcements/fda-brief-fda-collaborates-health-canada-and-uks-mhra-foster-good-machine-learning-practice

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   How can regulatory agencies help foster good machine learning practice?

   • “With artificial intelligence and machine learning progressing so rapidly, our three regulatory agencies, together, see a global opportunity to help foster good machine learning practice by providing guiding principles that we believe will support the development and maturation of good machine learning practice.

   FDA In Brief: FDA Collaborates with Health Canada and UK’s MHRA to

   www.fda.gov/news-events/press-announcements/fda-brief-fda-collaborates-health-canada-and-uks-mhra-foster-good-machine-learning-practice

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   Do artificial intelligence and machine learning software changes need a premarket review?

   • Under the FDA’s current approach to software modifications, the FDA anticipates that many of these artificial intelligence and machine learning-driven software changes to a device may need a premarket review.

   Artificial Intelligence and Machine Learning in Software as a Medical

   www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device

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   How can machine learning improve the quality of patient care?

   • This will help stakeholders to advance device development, which has the potential to significantly improve the quality of patient care and transform health care. We recognize that machine learning technologies present unique considerations due to their complexity and the iterative and data-driven nature of their development.

   FDA In Brief: FDA Collaborates with Health Canada and UK’s MHRA to

   www.fda.gov/news-events/press-announcements/fda-brief-fda-collaborates-health-canada-and-uks-mhra-foster-good-machine-learning-practice

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4. www.fda.gov › news-events › press-announcementsFDA Releases Artificial Intelligence/Machine Learning Action ...

   www.fda.gov › news-events › press-announcements

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   Jan 12, 2021 · For Immediate Release: January 12, 2021. Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical ...

5. www.fda.gov › medical-devices › software-medicalArtificial Intelligence and Machine Learning in Software

   www.fda.gov › medical-devices › software-medical

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   • What Is Artificial Intelligence and Machine Learning?
   • Artificial Intelligence and Machine Learning News and Updates
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   Artificial Intelligencehas been broadly defined as the science and engineering of making intelligent machines, especially intelligent computer programs (McCarthy, 2007). Artificial intelligence can use different techniques, including models based on statistical analysis of data, expert systems that primarily rely on if-then statements, and machine ...

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   Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

   Public Workshop - Evolving Role of Artificial Intelligence in Radiological Imaging: February 25 - 26, 2020 External Link Disclaimer

   Discussion Paper: Proposed Regulatory Framework for Modification to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)

   Collaborative Communities: Addressing Health Care Challenges Together

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   If you have questions about artificial intelligence, machine learning, or other digital health topics, ask a question about digital health regulatory policies.

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   McCarthy, J. (2007). What Is Artificial Intelligence? Stanford University, Stanford, CA. Retrieved from http://jmc.stanford.edu/articles/whatisai/whatisai.pdfExternal Link Disclaimer

   See full list on fda.gov

6. www.fda.gov › medical-devices › software-medicalArtificial Intelligence and Machine Learning (AI/ML)-Enabled ...

   www.fda.gov › medical-devices › software-medical

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   Oct 5, 2022 · The FDA has updated the list of AI/ML-enabled medical devices marketed in the United States as a resource to the public. ... Good Machine Learning Practice for Medical Device Development: Guiding ...

7. www.fda.gov › news-events › press-announcementsFDA In Brief: FDA Collaborates with Health Canada and UK’s ...

   www.fda.gov › news-events › press-announcements

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   Oct 27, 2021 · Today, FDA, Health Canada and the UK’s MHRA jointly issued the “Good Machine Learning Practice for Medical Device Development: Guiding Principles” to identify a set of ten guiding principles ...

8. www.fda.gov › media › 145022Artificial Intelligence/Machine Learning (AI/ML)-Based.:Jf/<X

   www.fda.gov › media › 145022

   Machine Learning Practice (GMLP), and there was a call for FDA to encourage harmonization of the ... The discussion paper used the term Good Machine Learning Practice, or GMLP, to describe a set ...