June 22, 2011

In this Guidance Paper the FDA states the new approach and interpretation of the overall Human Factors Engineering Process. This document shall supersede the older guidance paper „Medical Device Use-Safety: Incorporating Human FactorsEngineering into Risk Management“ and combines old formalities with new findings of the Human Factors Engineering area.

An important topic of this paper is about conducting summative usability studies within the USA. The paper states that only studies incorporating US residents are valid for an FDA approval. Another topic with some impact factor is the calculation of the sample size of participants for certain Human Factors studies.

If you have any questions or anything seems unclear regarding this article do not hesitate to contact Thore Reitz.