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Latest / Health and life sciences

PolicyHealthUS Canada UKConfirmed

FDA, Health Canada and MHRA publish transparency principles for machine-learning devices

See how this story connects

Source: FDA: Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles

The FDA, Health Canada and the UK’s MHRA published joint guiding principles on transparency for machine learning-enabled medical devices in June 2024. They build on the three regulators’ 2021 good machine learning practice principles and set out who needs device information, what to disclose about intended use, development, performance and logic, and when and how to present it to clinicians and patients.

Why it matters

Makers of AI medical devices in the US, Canada and UK had a shared regulator statement on what to tell clinicians and patients about how their devices perform and reach outputs.

When
13 Jun 2024
ID
WTA-N-2024-0010
Who
FDA, Health Canada, MHRA

Summary by wheresthe.ai, from FDA. Checked against the source on 9 Oct 2026.

Read the original at FDA

Source copy: download the page as saved on 18 Oct 2026 (PDF). Also held by the Internet Archive.

Next stop on this Storyline: Led toFDA finalises guidance letting AI device makers pre-authorise planned model updates

Cite this story

WTA-N-2024-0010: “FDA, Health Canada and MHRA publish transparency principles for machine-learning devices.” wheresthe.ai, 13 Jun 2024. https://wheresthe.ai/d/intl-fda-hc-mhra-mlmd-transparency-principles-2024-06/ (source: FDA: Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles).

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