This is an obsolete copy of the 1998 guidance which was superseded May 11, 1998 by a new joint guidance from CDRH and CBER.
FDA CDRH’s Office of Device Evaluation “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”. (This guidance supersedes the August 1991 Guidance “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review”.) This guidance defines software to be submitted as part of a premarket submission to FDA (i.e., PMA, 510(k), IDE). As such it applies directly only to software that is part of a medical device or is a medical device itself. It is important to note there is a difference between what is required to include in a submission and what might be required upon request or during an FDA inspection. For products that use any off-the-shelf software refer to the companion guidance on what to include regarding OTS software in a submission. Note that one should always check to see if there is specific 510(k) guidance for that type of device you’re interested in. These device specific guidances often have sections on specific software requirements for that type of device that supplement or explain the more general requirements in this document.