OverviewAs the healthcare industry continues to transform through innovative technologies in the Artificial Intelligence space, the U.S. Food and Drug Administration (FDA) has taken further action to effectively regulate these devices. They have released an Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD) Action Plan outlining the discussion and requesting feedback. To review the plan and provide feedback, click on the article above.
How can Stat One help?Stat One has helped many Artificial Intelligence (AI) clients get their products analyzed and approved by the FDA. Our team takes a focused approach based on FDA guidance for AI-related products. Utilizing our statistical expertise and industry knowledge, we can provide assistance for items such as:
- Study Design
- Sample Size Calculation
- Statistical Analyses
- Participation in FDA Discussions