The FDA issued the final guidance, Application of Human Factors Engineering Principles for Combination Products: Questions and Answers, to help facilitate the development of combination products. This guidance contains questions and answers for industry on applying human factors engineering (HFE) principles to the development of combination products. The guidance clarifies how the unique aspects of a combination product influence the considerations within the HFE process.
This guidance finalizes the February 2016 draft version entitled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. Changes from the draft to the final guidance include deleting human factors information that is redundant with other FDA guidance documents, clarifying the combination product critical task definition, and further explaining considerations to help identify combination product critical tasks.
See the announcement for more information.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!