Interactive visualization of FDA 510(k) clearances for Software as a Medical Device (SaMD). Explores regulatory trends, predicate device networks, and clearance timelines across product codes.
Interactive visualization of FDA 510(k) clearances for Software as a Medical Device (SaMD) — predicate networks, clearance timelines, and product code analysis.
Explores the FDA's 510(k) Premarket Notification database for software-as-a-medical-device submissions. Visualizes predicate device relationships, clearance trends over time, and regulatory pathways by product code.
Why It Exists
Understanding the SaMD regulatory landscape — which products get cleared, how they reference each other as predicates, and how clearance patterns shift over time — is valuable for regulatory strategy in health tech.
