Everything you Need to Know about SaMD from an FDA Perspective
Global Medical Device Podcast powered by Greenlight Guru
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Is S-a-M-D a Medical Device?
A lot of medical devices contain or include firmware or some type of software. FDA has had some pilot programs primarily focused on S-A-M-D that based on some of the publications they've just put out, they're looking to extend some of those programs into the S-I-M-d space as well. But I would think about them fundamentally differently because for a software as a medical device, you're thinking again about those outputs being your primary risk to, let's say, to a patient.
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