FDA wants women to be better represented in medical-device studies

Food and Drug Administration wants medical-device developers and manufacturers to improve the representation of women in their medical studies.

On Dec. 16, FDA announced its recommended guidelines for the design of medical-device studies that would better account for differences that exist between males and females in the effectiveness of devices.

A 2001 report by Government Accountability Office found that 52 percent of people who were enrolled in studies were female, but only 30 percent of the studies accounted for results according to the sex of the participants.

FDA recommended the guidelines because it believes that the effectiveness of medical devices might be different for male and female users due to genetic, hormone or body-size differences.