“Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”. This guidance went direct to final without an opportunity for industry comment. Based on this together with FDA’s Good Guidance Practices FDA believes it does not substantively change recommendations made in the prior version of this guidance. Click on the link provided for the full guidance.
This is a new revised guidance issued May 11, 2005 jointly by FDA’s CDRH and CBER to replace the now obsolete 1998 version of this guidance.
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.
A few points to note are:
– Determination of level of concern is elaborated differently then in the prior guidance and attempts to clarify the distinction between moderate LOC and minor LOC.
– Provides clarifications on requirements and design specification to be provided
– Has new sections on Special and Abbreviated 510(k)s
– This guidance also applies to CBER regulated Blood Establishment Computer Systems (BECS).
– The guidance has been shortened to focus on submission requirements and much of the heuristic information in the prior guidance and its appendices has been eliminated
– A paragraph on virus protection software indicates that is beyond the scope of this guidance document.
– AAMI SW68 Medical Device Software — Software life cycle process and ISO 14971 Medical Device Risk Management are both mentioned.