The FDA issued a draft guidance intended for medical device developers and manufacturers that outlines recommendations for designing and conducting clinical studies that will enhance the number of women enrolled in the studies, according to an FDA news release.
A 2001 report by the U.S. Government Accountability Office found that while women represented 52 percent of study enrollees, 30 percent of studies did not report outcomes by sex and almost 40 percent did not report enrollment demographics.
"The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, in the release. "Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices."
The FDA will accept comments on this draft guidance during a 90-day public comment period.
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A 2001 report by the U.S. Government Accountability Office found that while women represented 52 percent of study enrollees, 30 percent of studies did not report outcomes by sex and almost 40 percent did not report enrollment demographics.
"The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women and men in their device studies," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, in the release. "Our draft guidance outlines what we recommend for obtaining and improving the quality and consistency of sex-specific data on devices."
The FDA will accept comments on this draft guidance during a 90-day public comment period.
Related Articles on the FDA:
FDA Issues Draft Guidance on Humanitarian Use Device Classification
FDA Approves Intuitive Surgical's Single-Site Instrumentation for Gallbladder Surgery
FDA Finds Problems in Johnson & Johnson Contract Drug Factory