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FDA Issues Draft Guidance on Medical Device Software

Thursday, October 13, 2016  
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FDA Issues Draft Guidance on Medical Device Software

The Food and Drug Administration (FDA) issued draft guidance today for software that is designed to serve medical purposes.  The draft guidance, "Software as a Medical Device (SaMD): Clinical Evaluation" focuses on establishing the scientific validity, clinical performance, and analytical validity for a SaMD.  The draft guidance is intended to provide globally harmonized, risk-based principles of when and what type of clinical evaluation is appropriate for a particular SaMD.

The draft guidance was prepared in coordination with the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force (GHTF). IMDRF is made up of medical device regulators designed to accelerate international medical device regulatory harmonization and convergence. 

To learn more about IMDRF, please click here.

For years FDA has become increasingly involved in software and cyber regulation of medical devices, and MDMA continues to work with the agency to ensure that any final guidance are reasonable and predictable.