Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development | Federal Regulations · Congress.wiki

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FDA

Open for Comments

FDA-2015-D-4848

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

Documents

Comments

Description

Draft Guidance for Industry and FDA Staff; Availability OPEN

Comment Period OpensFeb 3, 2016

Comment Period ClosesMay 4, 2016

Type	Title	Posted	Comments	Status
Notice	Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Guidance for Industry and FDA Staff; Availability FR Doc: 2023-19404	Sep 8, 2023

Total Comments

2015-935

Patricia Love, Office of Combination Products

Office of Special Medical Programs

Office of Medical Products and Tobacco

Human Factors Studies and Related Clinical

Study Considerations in Combination Product

Design and Development