Medical device human factors submissions: identifying and understanding key differences in regulatory guidance across the globe
Event Type
Poster Presentation
TimeThursday, April 152:00pm - 3:00pm EDT
LocationMedical and Drug Delivery Devices
DescriptionTailoring medical device requirements across multiple countries is a complex process that manufacturers must address prior to product launch. This can be even more challenging as regulatory guidance differs per country and is often ever-evolving due to advances in science and technology, as well as changes in the geopolitical landscape. Human factors practitioners can aid medical device manufacturers with regulatory submissions by ensuring that the human factors requirements are appropriate for the intended launch market(s).

This work reviews requirements for complete human factors submissions for medical devices adhering to local regulatory guidance from regions across the globe. This analysis was based on harmonized global standards (International Electrochemical Commission, 2015 ; Food and Drug Administration, 2009) and relevant local regulatory guidance where available from a subset the following agencies from the International Medical Device Regulators Forum (IMDRF):

• Australia - Therapeutic Goods Administration
• China - China Food and Drug Administration
• Europe - European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
• United Kingdom - UK Medicines and Healthcare products Regulatory Agency (MHRA)
• United States - U.S. Food and Drug Administration

In order to effectively compare and contrast guidance documentation for complete human factors regulatory submissions, a list of core criteria was iteratively created by team members from a global human factors and user experience (UX) research consultancy that has prepared hundreds of documents for human factors submissions to regulatory agencies over the last 15+ years. The final list included the following:

• Country name
• Submission contents requirements
o Protocol / test plan contents
o Intended use specification
o Formative evaluations
o Use-related risk documentation
o Labeling
o Post-market analyses
o Validation testing
 Methodology requirements
• Sample size criteria
• Training requirements (e.g., untrained arm, length of decay)
• Participant previous experience requirements (e.g., naïve vs. experienced)
• Critical task determination process
• Task performance criteria (e.g., use error, close call, success)
• Simulated-use requirements
 Report contents requirements
• Raw data requirements
• Root cause analysis
• Other
o Timeline and path(s) to submission (e.g., pre-submission options)
o Expectation timing of next regulatory update for human factors submissions

The output of this work will be a framework for human factors practitioners to quickly compare and contrast key similarities and differences across regulatory guidance when planning for upcoming human factors submissions with multi-country launch objectives.