Canada: Regulators from the United Kingdom, the United States and Canada published guiding principles for good machine learning practices for medical devices

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Description

Regulators from the United Kingdom, the United States and Canada published guiding principles for good machine learning practices for medical devices

On 27 October 2021, the health regulators of the United States Food and Drug Administration, Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency published ten guiding principles for the “good machine learning practice for medical device development”. The recommendations outlined by the agencies aim to improve and ensure the safety, effectiveness and quality of the medical devices that utilize artificial intelligence and machine learning. Some of the principles are: ensuring the use of multi-disciplinary expertise in the product life cycle, implementation of “good software engineering and security practices” and focusing on the performance of the human-artificial intelligence team.

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Scope

Policy Area
Registration and licensing
Policy Instrument
Algorithm design and technical standards
Regulated Economic Activity
ML and AI development
Implementation Level
bi- or plurilateral agreement
Government Branch
executive
Government Body
other regulatory body

Complete timeline of this policy change

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2021-10-27
adopted

On 27 October 2021, the health regulators of the United States Food and Drug Administration, Health…