USA – FDA updates off-the-shelf software guidance to reflect least burdensome approach

The US Food and Drug Administration (FDA) has reissued a final guidance on off-the-shelf (OTS) software used by medical devices, which aims to reduce administrative burdens for medical device sponsors. It aligns more directly with the agency’s broader approach to medical device software as well as international consensus standards.

The guidance supersedes an earlier version that was released in 2019 that focused on using hazard analysis to determine whether the software was fit for use. The previous version of the guidance relied on the agency’s then-current understanding of how OTS software was being incorporated into products. The agency said it has since learned much more about how OTS products function and has updated the guidance in line with its recent learnings.

“The least burdensome approach was applied to identify the minimum amount of information that, based on our experience, would generally be needed to support a premarket submission for a device that uses OTS software,” said FDA…