Creating a free account will enable you to subscribe to our daily and weekly email newsletters, as well as customize your reading experience to show only the categories most relevant to you.
Signing up only take a few minutes, so why not give it a try and see what you've been missing out on.
The U.S. Food and Drug Administration (FDA) mandates adequate enrollment of women in post-approval studies (PAS) of medical devices to ensure that any sex differences in device safety and effectiveness are not overlooked. A group of authors from the FDA report the results of a study evaluating the participation of women and analysis of sex differences in PAS in Journal of Women's Health, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers.
Women may respond differently to medical devices due to factors such as genetics, body size, hormones, or other intrinsic sex-specific or extrinsic societal or environmental factors. They may face greater or lesser risk of adverse events or derive more or less benefit. "Based on these findings, FDA implemented new procedures to ensure participation by sex is evaluated in PAS reviews," state the authors in their article "Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration."
"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 Susan G. Kornstein, MD, Executive Director of the Virginia Commonwealth University Institute for Women's Health, Richmond, VA, and President of the Academy of Women's Health.
Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration, Authors: Ellen Pinnow, MS, Naomi Herz,BS, Nilsa Loyo-Berrios, PhD, and Michelle Tarver, MD, PhD, Journal of Women's Health - doi:10.1089/jwh.2013.4343
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our Women's Health / Gynecology category page for the latest news on this subject.
Please use one of the following formats to cite this article in your essay, paper or report:
Liebert, Mary Ann. "Are enough women included in medical device studies, as required by the FDA?." Medical News Today. MediLexicon, Intl., 27 Jan. 2014. Web.
20 Apr. 2014. <http://www.medicalnewstoday.com/releases/271676>
Liebert, M. (2014, January 27). "Are enough women included in medical device studies, as required by the FDA?." Medical News Today. Retrieved from
Please note: If no author information is provided, the source is cited instead.
If you write about specific medications, operations, or procedures please do not name healthcare professionals by name.
For any corrections of factual information, or to contact our editorial team, please use our feedback form. Please send any medical news or health news press releases to:
Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.
This page was printed from: http://www.medicalnewstoday.com/releases/271676.php
Visit www.medicalnewstoday.com for medical news and health news headlines posted throughout the day, every day.
© 2004-2014 All rights reserved. MNT is the registered trade mark of MediLexicon International Limited.