Everything you Need to Know about SaMD from an FDA Perspective
Global Medical Device Podcast powered by Greenlight Guru
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Risks and Benefits of SAMD Outputs
FDA's definition of SAMD is a little bit long-winded, but I'll actually read it if you don't mind. A SAMD can best be described as software that utilizes an algorithm that operates on data input or digitized content to produce an output intended for medical purpose. That would be all the, hopefully, a lot of your listeners and these companies that may be developing SAMD. And the risks and benefits posed by SAMD outputs are largely related to the risk of inaccurate or incorrectoutputs.
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