The U.S. Food and Drug Administration (FDA) has crafted recommendations for designing and conducting medical device clinical studies to enhance the enrollment of women in appropriate trials.
The agency noted that certain medical products may elicit different responses in women than in men, due, in part, to basic differences between the genders, such as genetics, hormones, body size, diet, and sociocultural issues.
In addition, certain illnesses may be more common in women and may be responsible for differences in the safety and effectiveness of medical devices between genders.
The FDA is seeking input on its proposal for the next 90 days.
