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Medical Device Software: Considerations for Device and Risk Characterization

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Software as a Medical Device

A Proposed Document by the International Medical Device Regulators Forum (IMDRF), Software as a Medical Device Working Group, is provided below for public comment. 

Thank you for your contribution in reviewing and providing feedback for this document. 

Consultation documents

Medical Device Software: Considerations for Device and Risk Characterization

Please use the comments template to provide comments on the Proposed Document and send comments to email: IMDRFSaMDWG@fda.hhs.gov with the subject line ''Public Consultation on Medical Device Software: Considerations for Device and Risk Characterization" 

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