Common human factors engineering pitfalls in combination product usability studies Common Human Factors Engineering Pitfalls in Combination Product Usability Studies Regulatory Affairs Context The integration of human factors engineering (HFE) into the development of combination products and devices is of paramount importance to ensure patient safety and product effectiveness. The FDA defines combination products as those that involve a combination of drug, device, and/or biological product components. Regulatory Affairs (RA) professionals play a critical role in navigating the complex landscape of regulations and guidelines, particularly concerning FDA human factors engineering expectations. As outlined by the FDA, compliance with usability engineering…

Regulatory strategy for human factors submissions in NDA/BLA combination products Regulatory strategy for human factors submissions in NDA/BLA combination products The integration of human factors engineering (HFE) into the development of combination products is essential for ensuring usability, safety, and efficacy. Understanding and implementing a regulatory strategy for human factors submissions in New Drug Applications (NDA) and Biologics License Applications (BLA) is critical for regulatory affairs professionals in the pharmaceutical and biotech industries. This article provides a comprehensive overview of the relevant regulations, guidelines, agency expectations, and practical approaches to managing human factors engineering in combination products, particularly in the…

Vendor Oversight for Combination Product Human Factors Engineering Activities Vendor Oversight for Combination Product Human Factors Engineering Activities Human Factors Engineering (HFE) is a critical aspect of the development of combination products and medical devices, ensuring that the end user can effectively and safely use the product. For Regulatory Affairs (RA) professionals, understanding the regulatory framework surrounding HFE and how to appropriately oversee vendors conducting related activities is paramount in achieving compliance and successful market authorization. This article serves as a practical guide, detailing the relevant regulations, documentation requirements, and agency expectations concerning FDA human factors engineering and vendor oversight…

Incorporating patient feedback into FDA human factors engineering for devices Incorporating Patient Feedback into FDA Human Factors Engineering for Devices Context The integration of human factors engineering (HFE) into the design and evaluation of combination products and devices is critical for enhancing usability and ensuring patient safety. In the regulatory landscape of the US, the FDA emphasizes user-centered design principles in the development of these products. This article provides an in-depth analysis of FDA expectations regarding human factors engineering, focusing on how patient feedback can be effectively incorporated to produce safer, more effective devices. Legal/Regulatory Basis The FDA human factors…

Global alignment of FDA human factors engineering with EU MDR and UKCA requirements Global Alignment of FDA Human Factors Engineering with EU MDR and UKCA Requirements The integration of human factors engineering (HFE) into the design and development of combination products and medical devices is a critical component that ensures safety and efficacy. This article provides a detailed exploration of the regulatory landscape surrounding FDA human factors engineering and its alignment with the European Union Medical Device Regulation (EU MDR) and UK Conformity Assessment (UKCA) marking requirements. It serves as a comprehensive guide for regulatory affairs professionals as they navigate…