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FDA Deliver Final Guidance on the Clinical Evaluation of Software as a Medical Device (SaMD)

US FDA final guidance on clinical evaluation of software as a medical device (SaMD) is now published 

 

The guidance is based on the Medical Device Regulators Forum (IMDRF) SaMD Worknig Group and according to the agency they will be used to develop more specific SaMD clinical evaluation guidance in the future.

Goals of SaMD clinical evaluation

According to the guidance, effective SaMD clinical evaluation should include three major components:

 

  • Valid clinical association between a SaMD’s output and its targeted clinical condition
  • Analytical validation showing that a SaMD correctly processes input data and generates accurate, reliable and precise output data
  • Clinical validation showing that using a SaMD’s output data achieves the product’s intended purpose in terms of clinical care

Emergo, US Medical Device blog

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