On February 3rd, the Food and Drug Administration (FDA) published the Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development draft guidance.
As noted in the Introduction and Scope:
This guidance describes Agency recommendations regarding HF information in a combination product investigational or marketing application and clarifies the different types of HF studies; the recommended timing and sequencing of HF studies; and how HF studies are part of the process to maximize the likelihood that the combination product user interface is safe and effective for use by the intended users, uses, and environments. In addition, the guidance describes how HF studies relate to other clinical studies. The guidance also provides process considerations for HF information in investigational or marketing applications to promote development and timely review of safe and effective combination products. (p. 2)
The comment period for the draft guidance is open until May 3rd. For those interested in submitting electronic or written comments, visit this link for details.
