The FDA has recently published draft guidance regarding the content of premarket submissions for device software functions. The guidance provides information on the recommended documentation to include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions.

Our easy-to-read fact sheet outlines what the guidance covers, what you need to consider regarding documentation level, and a quick comparison between this guidance and IEC 62304. You can download the resource by clicking on the Download button below.