14594: Female FDA Investigators and Medical Device Plant Inspections (session 25903)

The Food and Drug Administration (FDA) inspects medical device manufacturing plants to ensure compliance with federal standards, ideally applying these standards objectively. However, gender-related research indicates that men and women may perform certain types of work, such as inspections, fundamentally differently. We examine whether the gender of FDA investigators influences the inspection outcome given and the subsequent quality of medical devices manufactured at the plant. We theorize that female FDA investigators assign the most serious inspection outcome, an Official Action Indicated (OAI), more frequently than male investigators and that OAIs assigned by female investigators will lead to higher quality products manufactured at the plant than OAIs assigned by male investigators. Analyzing 8,989 inspections conducted at 3,468 U.S. plants from 2003 to 2019, we find that female investigators are 48% to 93% more likely to assign OAIs, depending on the modeling approach employed. In addition, OAIs assigned by female investigators lead to higher quality products compared to OAIs assigned by male investigators, reducing the hazard of a product quality-related adverse event by approximately 74%. Instrumental variable analysis indicates a low risk of endogeneity bias and post-hoc analysis demonstrates support for a mechanism that helps explain our results: female investigators on average take three days, or 21%, longer conducting an inspection that results in an OAI; this longer time partially mediates the relationship between female investigators and OAIs. Our findings contribute to research on inspections and gender diversity while offering implications for the FDA and industry. These implications are both an awareness of the unique value brought by female FDA investigators as it pertains to medical device plant inspections and resultant product quality, as well as a starting point for the FDA in understanding what may be done to leverage this knowledge to improve public health.

view paper (if available)