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Chapter 31: Human Factors Regulations and Standards in Combination Product Development: IEC 62366 and FDA Guidance Documents

  • Melissa R. LemkeEmail author
  • Deborah Billings Broky
Chapter
  • 65 Downloads
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 35)

Abstract

Human factors engineering is an important part of combination product development, and regulatory bodies expect certain human factors standards to be met for successful pre-market submissions that demonstrate a product is safe and effective in the hands of end users. This chapter identifies US and international human factors standards for combination products and examines best practices used to develop use-related product documentation that forms the framework of a sponsor’s human factors program, for example, use-related risk analyses (URRA). In addition, strategic implementation of human factors methodologies are discussed in terms of how to (1) start the human factors process early, (2) leverage applicable prior work, (3) keep the global market in mind, and (4) collect labeling-focused data. Challenges that sponsors often encounter during human factors validation testing are also explored, which can include accounting for negative transfer, cautiously relying on training or labeling as a mitigation, providing data-driven design decisions, creating quick reference guides, and determining how to confirm delivery of a full dose.

Keywords

Human factors Usability Validation testing Training Instructional materials Use-related risk User interface 

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Copyright information

© American Association of Pharmaceutical Scientists 2020

Authors and Affiliations

  1. 1.Agilis Consulting Group, LLCCave CreekUSA

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