ARTICLE SUMMARY:
Health Canada has issued a draft guidance on premarket expectations for machine learning-enabled devices. Excerpted from Pathways’ Picks August 30: Canada Drafts Machine Learning Guide, Labs Speak Out, and More.
Health Canada posted a draft guidance August 30 outlining its expectations for premarket submissions of machine learning-enabled devices. The draft details how companies should go about demonstrating safety and effectiveness of such devices, and it address issues like bias, drift, training data, and transparency. The document also offers the opportunity for predetermined change control plans (PCCPs) as mechanism for companies to get pre-authorization from Health Canada for planned software updates, aligning in many respects with FDA’s March draft guidance on PCCPs for AI/ML devices. Comments on Health Canada’s document are due October 29.