The U.S. Food and Drug Administration (FDA) has mandated greater inclusion of women in post approval studies for medical devices, to reduce gender bias related to safety and effectiveness of these devices.
A peer reviewed study by the FDA illuminates the importance of an adequate level of women’s participation in post approval studies (PAS) and the analysis of sex differences. According to the researchers, from the FDA’s Center for Devices and Radiologic Health, women may react differently to medical devices, based on factors such as genetics, body size, hormones, or other intrinsic sex-specific or extrinsic societal or environmental factors, Parent Herald reports. With these factors in mind, the FDA reconsidered previous polices and came up with new measures to ensure maximum participation of women in PAS reviews. “Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews,” the authors write. The article was published online January 9 in the Journal of Women’s Health.
“It is critically important that we have adequate participation of women in clinical trials, and that we analyze sex differences in study outcomes and adverse events,” says editor-in-chief Dr. Susan G. Kornstein, who is executive director of the Virginia Commonwealth University Institute for Women’s Health, and is president of the Academy of Women’s Health, wrote in a news release.
In the abstract of the article, the authors write that the FDA will work with applicants “to develop PAS that enroll and retain proportions of women consistent with the sex-specific prevalence for the disease or condition the device is used to treat.”