The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development



This document provides guidance to industry and FDA Staff on the underlying principles of human factors (HF) studies during the development of combination products as defined under 21 CFR Part 3.

Go back

GMP Conferences by Topics