Guideline

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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Internet:	http://www.fda.gov/cdrh/ode/guidance/337.pdf
Origin/Publisher:	FDA
Content:	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.
Status:	Guidance
Document Type:	Guidance