last highlighted date: 2024-12-09
Highlights
- SaMD has the potential to revolutionize healthcare. By providing clinicians with access to real-time data and insights, SaMD can help them make better patient care decisions. SaMD can also be used to provide patients with more control over their own health.
- On April 2, 2019, the FDA published a discussion paper “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) — Discussion Paper and Request for Feedback” that describes the FDA’s foundation for a potential approach to premarket review for artificial intelligence and machine learning-driven software modifications. This paper discussed A total product lifecycle regulatory approach for AI/ML-based SaMD. The paper treats AI/ML-based SaMD as a distinct entity from conventional SaMD which follows processes such as premarket clearance (510(k)), De Novo classification, or premarket approval.