CDS Coalition Comments Applaud CDRH’s Digital Health Innovation Action Plan but Encourage Greater Agency Focus on Machine Learning
On September 29, 2017, the Coalition provided comments to FDA’s Digital Health Innovation Action Plan docket. The comments applaud the release of the Action Plan, and highlight the importance of increased FDA attention and focus on machine learning. Specifically, the Coalition suggests that FDA consider participating in a mock presubmission meeting to improve understanding of issues that arise in submissions that include machine learning intended for CDS software.