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

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

https://www.gmp-compliance.org/files/guidemgr/Human-Factors-Studies-and-Related-Clinical-Study-Considerations-in-Combination-Product-Design-and-Development.pdf

Origin/Publisher:

FDA

Content:
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.

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