International – Regulators issue Good Machine Learning Practice guiding principles for AI/ML medical device development

Medical device regulators in the US, UK and Canada have published 10 guiding principles intended to help establish Good Machine Learning Practice (GMLP) for medical devices utilizing artificial intelligence and machine learning, or AI/ML.

Regulators including the US Food and Drug Administration, UK Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada developed the GMLP principles in an effort to map out key areas of AI/ML oversight focus for the International Medical Device Regulators Forum (IMDRF), international standards organizations and other stakeholders.

Areas for possible collaboration between these stakeholders, according to the principles, include:

  • Research
  • Creating educational tools and resources
  • International harmonization of regulations
  • Consensus standards to inform regulations and guidelines…