This post was written by Erin Janssen. The FDA recently issued draft guidance entitled “Evaluation of Sex Differences in Medical Device Clinical Studies,” which indicates FDA’s current view of the study and evaluation of sex-specific differences in medical device clinical trials to support marketing submissions and post-approval study. In particular, the focus is on addressing potential differences in study design, conduct, outcomes, and interpretation that should be considered to ensure sex-specific issues are adequately addressed. The intent of the guidance is to improve the quality and consistency of available data regarding the performance of medical devices in both sexes, to encourage proportional enrollment of women representative of disease demographics and provide guidance on reporting of sex-specific information. Although comments can be submitted at any time, FDA is requesting that interested parties submit their comments by March 19, 2012.
