Articles tagged with “de-novo-pathway”

FDA SaMD Classification: AI & Machine Learning Guide

Understand FDA SaMD classification for AI/ML devices. Review risk levels (Class I-III), 510(k) pathways, and regulatory guidelines for medical software.

20 min read

2/9/2026

fda regulation samd classification ai medical devices machine learning 510(k) clearance de novo pathway software as a medical device regulatory compliance