New US FDA guidance: Content of Human Factors Information in Medical Device Marketing Submissions

Released in May 2026, the FDA’s final guidance titled Content of Human Factors Information in Medical Device Marketing Submissions, presents an updated, risk-based framework to guide manufacturers on what human factors engineering (HFE) information should be included in medical device marketing submissions. For medical device manufacturers, this guidance has immediate implications on development processes, validation requirements, and submission strategies.

Building on its experience with the 2022 draft guidance, the FDA has refined expectations for when and how HFE data should be included. The result is a more structured approach to demonstrating use-safety and effectiveness, while also introducing new considerations that may create challenges if misunderstood. Organizations that fail to adapt risk delays, additional scrutiny or rejected submissions.

In this webinar, Emergo by UL’s Senior Research Directors will break down what has changed, what remains consistent, and how to operationalize the new requirements. The session will provide practical interpretation of the guidance and highlight real-world implications for teams preparing submissions across device classes.

About our presenters

Allison Strochlic, Senior Research Director

Allison was one of the co-founders of the Emergo by UL Human Factors Research and Design team in 2005. She has spent her career applying human factors engineering principles to medical and pharmaceutical product development. She advises global clients on aligning HFE activities with FDA and international regulatory expectations, including leading engagements and regulatory interactions.

Allison co-authored Usability Testing of Medical Devices and contributes regularly to industry publications. She is an editor for Human Factors in Healthcare and frequently presents at conferences and webinars. She is a Certified Human Factors Professional with degrees from Tufts University and Bentley University.

Merrick Kossack, Senior Research Director

Merrick brings more than 25 years of experience helping organizations develop strategies to address complex human factors challenges. His expertise includes integrating HFE into product development processes, leading advanced usability studies, and shaping regulatory strategy for high-risk systems.

He holds an MS in Human Machine Systems Research from Georgia Tech and a BS in Industrial Engineering from the University of Illinois. Merrick contributes to leading industry standards through AAMI and IEC committees and serves as faculty for AAMI training programs. He is also recognized as a Distinguished Member of Technical Staff within UL Solutions.