If anyone can explain why, it’s Rob. He writes, “90% of usability testing submitted to the FDA is unacceptable and the root cause is simply a failure to understand the human factors process.”

And continues, “Unlike CE Marking technical files, the FDA does not require a usability engineering file for all products.

Instead, the FDA determines if usability testing is required based upon a comparison of your device’s user interface and a competitor’s user interface (i.e. predicate device user interface). If the user interface is identical, then usability testing may not be required.

Instead, your company should be able to write a rationale for not doing usability testing based upon equivalence with the predicate device. If there are differences in your user interface, you will need to provide use-related risk analysis (URRA), identify critical tasks, implement risk controls, and provide verification testing to demonstrate the effectiveness of the risk controls.

Even if your device is “easier to use” or “simpler”, you still need to provide the documentation to support this claim in your submission. The FDA also does not allow comparative claims in your marketing for 510(k) cleared devices. Comparative claims require the support of clinical data.”

Rob will show you the 10 steps to deliver what you need to FDA and proceed without nasty surprises.