Global Medical Device Podcast powered by Greenlight Guru cover image

Everything you Need to Know about SaMD from an FDA Perspective

Global Medical Device Podcast powered by Greenlight Guru

00:00

SMD - What's It All About?

A growing segment of the medical device industry known as software as a med device or SMD. As part of the Cures Act, we did see that a number of software functions got excluded under Section 520, Part O. FDA is not going to regulate it as a device, at least for now based on what they've put out and published.

Transcript
Play full episode

The AI-powered Podcast Player

Save insights by tapping your headphones, chat with episodes, discover the best highlights - and more!
App store bannerPlay store banner
Get the app