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

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.