[Emergo, UL] Mapping Out a Global Human Factors Validation Strategy

Historically, the U.S. has been the leader in medical product human factors (HF) engineering maturity with stringent regulatory enforcement, followed by the European Union (EU) with less stringent regulatory enforcement, while most other global regions have had little or no HF guidance or enforcement. However, in the past few years, the global regulatory landscape has continually evolved as other countries including China, Japan and the U.K. have introduced and enforced their own guidance. As a result, manufacturers seeking to market medical products globally must develop a global HF plan to meet these current and evolving requirements. In this article, we explore common questions when forming a global HF validation testing strategy, including one of the most pressing questions: In which countries should HF validation testing be conducted?  

 

Global regulatory expectations for HF validation testing

When developing an HFE plan to bring a product to multiple markets, manufacturers must have a baseline understanding of HF validation testing requirements in different regions to optimize a testing plan. Below, we summarize the key requirements for different regions.  

• U.S.: The Food and Drug Administration’s (FDA) final HF guidance calls for testing to be executed in the U.S. with U.S. residents, and they are unlikely to accept HF validation data collected outside of the country.  

• EU/U.K./Japan: These regions will likely accept HF validation data collected outside the country (including data collected from U.S.-based tests) if manufacturers can justify market equivalency (i.e., sufficient similarity between a product’s intended use, users and use environments).  

• China: The National Medical Products Administration (NMPA) might accept HF validation data collected outside the country, depending on factors such as use-risk classification and product novelty. However, manufacturers should also plan to justify use, user, use environment and risk equivalency and/or perform a comparative analysis to demonstrate equivalency with a device on the market if applicable.  

 

Mapping Out a Global Human Factors Strategy | Emergo by UL

Mapping Out a Global Human Factors Validation Strategy

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