Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 21 December 2011
The Food and Drug Administration (FDA) issued a draft guidance last week to address the historic underrepresentation of women in clinical studies. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate. A 2001 report by the US Government Accountability Office on FDA-reviewed drug studies found that while women represented 52 percent of study enrollees, 30 percent of study documents did not report outcomes by sex and nearly 40 percent did not report enrollment demographics. The draft guidance addresses study and evaluation of sex differences, data analysis and reporting in both pre- and post-market device clinical studies. In addition, it covers issues regarding statistical analyses of sex differences and how to report sex-specific information in summaries and labeling for approved devices. (FDA.gov)
Tags: women, clinical trials, medical device