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LOCATION:Gramercy
DTSTART;TZID=America/New_York:20260323T143700
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UID:HFESHCS_2026 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess143_LEC172@linklings.com
SUMMARY:A CUHF Case Study with FDA: Learnings for Industry
DESCRIPTION:Samantha Sye, Jennifer Soosaar, and Jack Giacomini (Core Human
  Factors, A Rimkus Company)\n\nCore Human Factors, Inc. conducted a compar
 ative use human factors (CUHF) study commissioned by the U.S. Food and Dru
 g Administration (FDA) to provide additional reference information to indu
 stry and to explore the application and challenges of the current Draft Gu
 idance on ANDA CUHF Studies. The primary objective of this research was to
  collect data intended to inform FDA’s pre-ANDA and ANDA internal review p
 rocesses and the advice FDA provides the generic drug industry.\n\nThe CUH
 F study compared a semi-automated pen injector to a manual pen injector, f
 ocusing on three “other design differences”: 1) Extended dose selector vs.
  no extension, 2) Visibility of other doses/markings on the extended selec
 tor, and 3) Manual (dynamic) push vs. automated (static) injection mechani
 sms. The primary objective of this study was to compare use success rates 
 for these two types of pen injector given these “other design differences”
  using a noninferiority design.\n\nThis presentation will discuss the know
 n challenges of conducting CUHF studies according to the Guidance and how 
 they were addressed in this study, including:\n•	Statistical Analysis Plan
  (SAP): determining error rates and corresponding sample sizes\n•	Study pa
 rticipant recruitment and use of surrogates\n•	Selection of tasks for eval
 uation\n•	Treatment of study artifacts\n\nSecondary objectives included ex
 ploring differences in use success rates for other dose delivery tasks and
  conducting qualitative root cause analyses of use events. \nStatistical a
 nalysis of the study results demonstrated that the Test Product (manual pe
 n) may be substitutable for the RLD (semi-automated pen) among experienced
  adult users, with no statistically significant increase in use error rate
 s for critical tasks impacted by differences in external critical design a
 ttributes.\n\nThis project was supported by the Food and Drug Administrati
 on (FDA) of the U.S. Department of Health and Human Services (HHS) through
  a contract 75F40123D00028/75F40123F19001. The presentation contents are t
 hose of the author(s) and do not necessarily represent the official views 
 of, nor an endorsement, by FDA/HHS, or the U.S. Government.\n\nTrack: Medi
 cal and Drug Delivery Devices\n\nSession Chair: Veronica Mendez (Core Huma
 n Factors, A Rimkus Company)\n\n
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