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GUIDANCE DOCUMENT

Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development Guidance for Industry and FDA Staff February 2016

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

Docket Number:
FDA-2015-D-4848
Issued by:
Guidance Issuing Office
Office of Combination Products
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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.  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.   


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-4848.