Instructions for Use (IFU) play an important role in any medical device or combination product packaging and far too often they are treated as an afterthought. Just like packaging, they are easily overlooked but the sooner you can start designing the better.
Research shows that 70% of human factors (HF) practitioners report design and content of instructions for use as common drivers of FDA requests for information (RFI) when reviewing HF protocols and submissions. In this recent article by MDDI, they breakdown this further to help readers understand the importance of developing an IFU and why it should be started early and alongside device development.
