Fig. 3
From: The role of machine learning in clinical research: transforming the future of evidence generation
FDA-proposed workflow to regulate machine learning algorithms under the Software as a Medical Device framework. From: Proposed regulatory framework for modifications to artificial intelligence/machine learning (AI/ML)-based software as a medical device: Discussion paper and request for feedback. https://www.fda.gov/media/122535/download. Accessed 17 May 2020