Table 4 FDA’s directive requiring “gender bias” assessment for medical devices
The FDA’s Office of Device Evaluation directed industry, when applying for approval of a new medical device, to address “gender bias” from two aspects in all Premarket Approval Applications and Summaries of Safety and Effectiveness Data by responding to the following questions [47] |
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•“Was the selection ratio of men versus women in the study reflective of the underlying distribution of the disease for that given age group, ethnic group, stage of disease, etc.? Was any selection bias on the basis of gender identified during review?” |
•“Was there any difference in the safety and effectiveness of the device based on gender? For example, was the device more/less effective in women?” |