Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Guidance for Industry and FDA Staff; Availability
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Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled "Application of Human Factors Engineering Principles for Combination Products: Questions and Answers." This document provides 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 the regulations. The guidance clarifies how the unique aspects of a combination product influence the considerations within the HFE process. This guidance is intended to facilitate the development of combination products. This guidance finalizes the draft guidance entitled "Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development" issued on February 3, 2016.
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