Good Machine Learning Practices for Medical Device Development

Bernhard Kappe

Published on: November 1st, 2021

Many of you probably saw the announcement last week from the FDA on Good Machine Learning Practices for Medical Device Development: Guiding Principles. The document was put out jointly by the FDA and the equivalent regulators in the UK and Canada. Based on our initial reading, it does not cover new ground. In many ways, it can be looked at as a “cliff notes” version of the much more detailed 2018 Xavier Health Whitepaper on Good Practices for AI and Continuous Learning Systems in Healthcare.

It is important to note that this document is NOT the draft guidance on Marketing Submission Recommendations for a Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)- Enabled Device Software Functions that is on the FDA’s B list for 2021. We’ve been told that the guidance document has been developed, but the FDA can’t publish it yet, and that this document, along with last month’s virtual public workshop on transparency, are intermediate deliverables.

Bernhard Kappe