Regulatory Blog

The U.S. Food and Drug Administration (FDA) has issued a draft guidance document titled “ Artificial Intelligence-Enabled Device Software...

The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...

The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...

The International Medical Device Regulators Forum (IMDRF) has published a draft guidance (01 July, 2024) "Good machine learning practice...

A new submission has been accepted into the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program by...

The World Health Organization (WHO) released new guidelines (18 January 2023) on ethics and governance of large multi-modal models...

Earlier today (25 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Software...

Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...

Artificial Intelligence (AI) is a broad term that encompasses many different things and is a kind of intelligence that is created by a...