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GUIDANCE DOCUMENT

Application of Human Factors Engineering Principles for Combination Products: Questions and Answers Guidance for Industry and FDA Staff September 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-D-4848
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products

This document contains questions and answers for industry and FDA staff on the application of human factors engineering (HFE) principles to the development of combination products as defined under 21 CFR part 3. This guidance finalizes the February 2016 draft version entitled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. This guidance provides information in a question and answer format and clarifies how the unique aspects of a combination product influence the considerations within the HFE process.   

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