The infographic provides insights into the Software as a Medical Device (SaMD) regulatory landscape in the United States.

SaMD Approvals in US Market Over the Years

A line graph shows the number of annual SaMD approvals by the US FDA from 1995 to 2024.

Approvals remained low and inconsistent until 2015, with numbers generally in single digits or low teens.

https://www.freyrsolutions.com/infographics/samd-regulatory-scenario-for-us