X Close

This hyperlink will direct you to a non-governmental Website or application.

The appearance of external hyperlinks does not constitute endorsement by the United States Department of Health & Human Services (HHS) of the hyperlinked Website or application, or the information, products or services contained therein. Such hyperlinks are provided consistent with the intended purpose of this HHS Website. Visitors to the hyperlinked Website or application will be subject to the Website or application's privacy policies. These practices may be different than those of this HHS Website.

You will be redirected to: link

FDA Seeks to Get More Women Into Trials of Medical Devices

One study found women accounted for only one-third of those in major trials.

FRIDAY, Dec. 16 (HealthDay News) -- Draft recommendations meant to increase the number of women in clinical trials for medical devices were released Friday by the U.S. Food and Drug Administration.

Genetics, hormones, body size, diet, social and cultural factors, and types of illness may cause women to respond differently to certain medical products and devices than men, according to the FDA.

But, women are typically underrepresented in clinical trials. For example, a 2009 study of applications for approval of cardiovascular devices found that average female enrollment in important trials that included gender information was only 33.9 percent.

The FDA's draft guidance -- intended for medical device developers and manufacturers -- includes recommendations for designing and conducting medical device clinical trials in a way that may increase the enrollment of women, said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

"The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies," he said in an FDA news release. "Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices."

The document covers study and evaluation of sex differences, data analysis, and reporting in clinical studies conducted both before and after market approval. It also deals with statistical analyses of sex differences, how to report sex-specific information in summaries, and sex-specific labeling for approved devices.

There is a 90-day public comment period on the draft guidance.

More information

Here's where you can find the draft guidance.

(SOURCE: U.S. Food and Drug Administration, news release, Dec. 16, 2011)

HealthDayNews articles are derived from various sources and do not reflect federal policy. healthfinder.gov does not endorse opinions, products, or services that may appear in news stories. For more information on health topics in the news, visit Health News on healthfinder.gov.