Q&A Guidance Clarifies Human Factors Testing For Combination Products

A highly anticipated final guidance from the FDA on Human Factor Studies answers frequently asked questions about human factor studies when designing combination products.

A woman opens an auto injector by taking off the blue cap. — • Source: Shutterstock

In the long-awaited final guidance, Application of Human Factors Engineering (HFE) Principles for Combination Products: Questions and Answers, the US Food and Drug Administration addresses frequently asked questions about human factor studies in combination product design and development.

The guidance, published 8 September, is written in an uncharacteristic question-and-answer format responding to 15 frequently asked questions about human...