FDA Mandates Woman Participation in PAS Studies For Medical Devices

Parent Herald January 24, 09:45 am

Post Approval Studies need women participation to get proper review of devices, says FDA

The U.S. Food and Drug Administration mandates inclusion of women in post approval studies for medical devices. According to FDA officials, the inclusion of women is necessary to cut down any gender bias related to safety and effectiveness of these devices.

A  peer reviewed study by FDA illuminates the importance of woman participation and analysis of sex differences in post approval studies(PAS) in Journal of Women's Health.

According to the researchers, women may react differently to the medical devices, based on different factors like genetics, body size, hormones, or other intrinsic sex-specific or extrinsic societal or environmental factors. Are there any benefits from the devices or any adversial effects.

Keeping all these factors in mind, FDA had to reconsider their 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," stated the authors in their article, 'Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration." The article is available on the latest issue of Journal of Woman Health Website.

The importance of women for PAS studies can nevertheless be undermined, according to the experts in this field. "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," said Susan G. Kornstein, MD, Executive Director of the Virginia Commonwealth University Institute for Women's Health, in a press release.

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