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USFDA Guidance: Artificial Intelligence-Enabled Device Software Functions – Lifecycle Management and Marketing Submission Recommendations
The U.S. Food and Drug Administration (FDA) has issued a draft guidance document titled “ Artificial Intelligence-Enabled Device Software...
Sharan Murugan
Jan 72 min read
19 views
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USFDA Draft Guidance: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision
The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...
Sharan Murugan
Jan 72 min read
32 views
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New EU Regulations on AI in Medical Devices: Key Insights and Implications
The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...
Sharan Murugan
Jul 15, 20242 min read
84 views
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IMDRF Guidance: Good Machine Learning Practice for Medical Device Development: Guiding Principles
The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...
Sharan Murugan
Jul 3, 20242 min read
23 views
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USFDA's ISTAND Pilot Program: Accepts First Submission of AI-Based Digital Tech for Neuroscience
A new submission has been accepted into the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program by...
Sharan Murugan
Jan 23, 20242 min read
56 views
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WHO Guidance: Ethics and Governance of Artificial Intelligence for Health
The World Health Organization (WHO) released new guidelines (18 January 2023) on ethics and governance of large multi-modal models...
Sharan Murugan
Jan 20, 20241 min read
100 views
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UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
Earlier today (25 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Software...
Sharan Murugan
Oct 25, 20231 min read
42 views
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USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...
Sharan Murugan
Mar 30, 20231 min read
58 views
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Artificial Intelligence in Regulatory Affairs
Artificial Intelligence (AI) is a broad term that encompasses many different things and is a kind of intelligence that is created by a...
Sharan Murugan
Sep 21, 20223 min read
4,183 views
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