Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

PDA congratulates CDER, CDRH, and OCP for working together to produce this draft guidance. This is a significant step forward in providing clarity in a difficult area. In order to maximize clarity and avoid duplicate or conflicting information, PDA recommends that this new guidance be built upon the foundation of the CDRH Final Guidance: Applying Human Factors and Usability Engineering to Optimize Medical Device Design and/or the IEC standard: Human Factors Engineering for Medical Devices. This new guidance document would then only address the new issues and special considerations regarding human factors that would apply to Combination Products (CP). PDA would be happy to work with FDA to develop additional guidance which addresses usability and human factors issues for generic or interchangeable biosimilar CPs and human factors issues for connected combination products. In addition, PDA recommends that this guidance title be changed to "Human Factors Study Considerations in Combination Product Design and Development." Given the definitions of HF and clinical studies, PDA encourages the FDA to change the references throughout the document to eliminate any confusion. HF studies and clinical studies have different purposes.