An Exciting Year of Human Factors Engineering (HFE) Regulatory Updates

By Allison Strochlic and Merrick Kossack  

2024 was an exciting year for Human Factors Engineering (HFE) with regulatory updates from the United States of America’s Food and Drug Administration (USA FDA), China’s National Medical Products Administration (NMPA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This article provides an overview of these important regulatory updates and highlights resources to help you understand their requirements.  

March 2024: China releases a final version of their HFE guidance 

On March 19, 2024, NMPA’s Center for Medical Device Evaluation (CMDE) released a final version of its guidance pertaining to the application of HFE to medical device development. Alongside this update, they released the finalized Guideline of usability engineering review for medical devices and a supplemental Application notes on the “Guideline of usability engineering review for medical devices”. Compliance to these documents has been required as of October 2024. Our team released an article discussing the differences between the draft and finalized NMPA guidance and delivered a detailed webinar reviewing the guidance’s requirements.  

March 2024: FDA releases artificial intelligence paper 

This year, discussions of innovation and technology have largely revolved around the subject of artificial intelligence (AI). In March of 2024, the FDA’s Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products (OCP) published a paper outlining the agency’s commitment to “protecting public health while fostering responsible and ethical medical product innovation through Artificial Intelligence.” This paper belongs to a wider FDA goal of developing a premarket review approach for AI and machine learning (ML) software modifications, joining their 2021 AI Action Plan and 2023 guidance Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. Our team released an article discussing the FDA’s current stance on AI/ML-enabled medical devices and the associated HFE challenges. We also recently delivered an engaging webinar discussing the role of AI in the practice of HFE.  

April 2024: Japan requires compliance with JIS T 62366-1:2022 

As of April 1, 2024, the Japanese regulatory authorities, the Ministry of Health, Labor and Welfare (MHLW) and the PMDA have required compliance with JIS T 62366-1:2022, Japan’s national HFE standard for medical devices. This update came with a notification informing industry of this conformity requirement and a Q&A document providing answers to frequently asked questions about compliance to the standard. Our team released an article discussing this regulatory update and its implications for industry.  

July 2024: FDA releases new use-related risk guidance 

On July 8, 2024, the FDA issued a new draft HFE Guidance document, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products. The guidance informs manufacturers of drug- and biologic-led combination products about the purpose and content of a use-related risk analysis (URRA) and how a URRA informs other human factors (HF) activities and can be used to support a marketing application or justification to forgo submitting HF validation study results. Our team released an article summarizing its requirements and outlining the content needed for a strong URRA. Coincidentally, just ahead of the FDA guidance’s release, our team presented a webinar and published a pair of articles that discuss the HFE activities and analyses that could be performed in lieu of an HF validation test. 

Looking ahead to 2025  

With the NMPA and PMDA both now requiring compliance with their HFE standards and the capabilities and scope of artificial intelligence set to further expand, 2025 is sure to be an interesting year full of exciting HFE challenges. As you prepare for your 2025 product development cycles and regulatory submissions, contact our team to learn more about HFE processes and the ever-evolving regulatory requirements. Or, sign up for a complimentary account with OPUS, our team’s software platform that provides access to a wide range HFE training modules, tools, and templates.  

Allison Strochlic and Merrick Kossack are Senior Research Directors at Emergo by UL.