The Food and Drug Administration issued draft guidance that addresses how device manufacturers can design and conduct clinical studies that encourage the enrollment of women in order to ensure appropriate representation of men and women.
FDA aims to boost inclusion of women in studies
Differences in genetics, hormones, body size, diet and social issues may affect the safety and efficacy of devices used for men and women, the FDA said in a news release announcing the guidance. According to the Dec. 16 draft guidance, women have been underrepresented or excluded from clinical studies.
“The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies,” said Dr. Jeffrey Shuren, director of the agency's Center for Devices and Radiological Health, in the news release.
The agency recommends that device manufacturers enroll representative proportions of men and women and include data about potential sex differences in study and submission documents. The FDA said it “strongly recommends that [manufacturers] investigate and report differences in study outcomes of treatment by sex.”
The FDA is accepting comments for 90 days.
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