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Food and Drug Administration, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) (full-text).


This guidance document is intended to provide information to industry regarding the documentation that we recommend you include in premarket submissions for software devices, including stand-alone software applications and hardware-based devices that incorporate software. This document is a result of ongoing efforts to state our recommendations more clearly and ensure they remain current as technology advances. This document also combines into one guidance recommendations previously included in two guidance documents.

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