Survey analysis on comparative use human factors processes.

Area of Science:

• Regulatory Science
• Human Factors Engineering
• Pharmaceutical Development

Background:

• Abbreviated New Drug Application (ANDA) pathway requires generic drug-device combination products to demonstrate pharmaceutical equivalence and device interchangeability.
• FDA draft guidance (2017) outlines requirements for Comparative Use Human Factors (CUHF) studies for these products.

Purpose of the Study:

• To survey human factors stakeholders on their experiences with the FDA's draft guidance for CUHF studies.
• To identify methods employed and potential gaps in the CUHF process for generic drug-device combination products.

Main Methods:

• A survey questionnaire (10 questions) followed by a virtual interview (30 min) was administered to human factors experts.
• Participants were involved in preparing generic combination products for FDA approval.
• Interview transcripts were analyzed through coding by topic.

Main Results:

• Human factors experts appreciate the systematic nature and specific expectations of the threshold analysis in the draft guidance.
• Key challenges include varying objectives compared to other FDA guidance, difficulties with sample size calculation, obtaining historical device data, and lack of methodology for error computation, categorization, and severity assessment.

Conclusions:

• Findings highlight areas for improvement in the FDA's draft guidance for CUHF studies.
• The identified requirements will inform the development of a proposed comparative human factors method.