ARTICLES BY NATALIE ABTS

  • Examining FDA’s New Patient Labeling Draft Guidance
    Examining FDA’s New Patient Labeling Draft Guidance

    In accordance with the increasing emphasis on human factors as it applies to medical products and their associated written materials, the FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.

Natalie Abts

Natalie Abts

Natalie Abts is the head of human factors engineering at Genentech, where she manages a team of engineers conducting human factors assessments for drug delivery devices. Before joining Genentech, Abts worked as a consultant providing advisement on human factors considerations for medical products. She has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Abts holds a master’s degree in industrial engineering, with a focus on human factors and ergonomics, from the University of Wisconsin, where she was mentored by Ben-Tzion Karsh.