The FDA issued a document on September 8, 2023 titled “Application of Human Factors Engineering Principles for Combination Products: Questions and Answers,” which is the final version of a draft guidance titled “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development” that was issued in 2016.
According to the document, “This guidance provides information in a question and answer format and clarifies how the unique aspects of a combination product influence the considerations within the HFE process.”
The final guidance covers 15 questions such as “What is the definition of a combination product critical task and how are combination product critical tasks identified?”; “What HF information and/or data should be provided to support initiating clinical investigations for a combination product?”; and “Does FDA expect the HF validation study that supports market authorization to be conducted at a certain development phase of the combination product?”
Read the FDA final guidance.
