By Patricia Anderson, MSE
Preparing proper documentation for an FDA submission can be a lengthy and daunting process. Luckily, when it comes to human factors specific documentation, Core can help you. An HFE/UE Summary Report is an important part of your FDA submission – it is the culmination of your research, design, and human factors (HF) process that defends your argument to FDA that your medical device or combination product is safe and usable.
Although it is called a “summary report,” FDA guidance lists many different sections that go in the report along with lengthy descriptions of what each section should contain. This report is key to getting your product on the market. Imagine that getting your device onto the market is like going to court. In that imagined scenario, you need to argue to the judge (FDA) that your product is innocent (safe and usable) beyond a reasonable doubt. The HFE/UE Summary report is your defense lawyer for your HF process. The report should be a carefully constructed story of how your iterative design process led you to the final product you are submitting, and should function as a strong argument of how you have mitigated all risks to the extent reasonably possible and why you believe your product is safe and usable for the intended users, uses and use environments.
At Core, we have years of experience writing HFE/UE Summary reports for products of various complexities. We have an intimate knowledge of the guidances FDA has released regarding what a recommended HF process should consist of and how these reports should be constructed. Lastly, we have constantly evolving methods of presenting the appropriate data in a way that accurately represents our clients’ development efforts and optimizes the report for efficient FDA review.
Need an HFE/UE Summary report? Look no further.