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

Issue Date: September 7, 2023
Issued by: Center for Biologics Evaluation and Research
Topic(s): Combination Products
Status: Final

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

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.

Download the Guidance Document

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