The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
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.
