Food and Drug Administration FDA released Good Machine Learning Practice for Medical Device Development: Guiding Principles developed in conjunction with Health Canada and the United Kingdom UK Medicines and Healthcare products Regulatory Agency MHRA.
Validating Software as a Medical Device (SaMD) designnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from designnews.com Daily Mail and Mail on Sunday newspapers.
This installation of Ropes & Gray s podcast series
Non-binding Guidance focuses on FDA regulatory
developments in the area of artificial intelligence
( AI ) and machine learning. AI and machine learning
represent a rapidly growing frontier in digital health, with
applications ranging from medical device software used for
diagnostic and triaging applications to drug candidate selection to
clinical trial design and interpretation. In this episode, FDA
regulatory attorneys Kellie Combs, Greg Levine, and Sarah
Blankstein explore the development and uptake of these technologies
in response to the ongoing COVID-19 pandemic, FDA s current
regulatory landscape for these technologies, recent steps FDA has
taken to update its regulatory approach to these tools in
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On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan
,” which describes the agency’s efforts to regulate products that incorporate AI. It is a direct response to stakeholder feedback to the April 2019 discussion paper
, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.” Although the Action Plan is light on details for AI regulation, it pledges specific actions that show FDA is moving forward with its “Predetermined Change Control Plan” regulatory framework for machine learning devices. The docket