
Everything you Need to Know about SaMD from an FDA Perspective
Global Medical Device Podcast powered by Greenlight Guru
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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.
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