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

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

FDA

Inhalt:
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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