FDA - "Considering Women’s Needs in Developing Medical Devices: Here’s ‘HoW’"

Link here. Excerpt:

'Women differ from men in anatomy, physiology, risk factors and disease symptoms. They are also likely to use more medical devices over the course of their lives than men do.

That is why FDA is actively trying to learn more about how medical devices uniquely affect women, and how women can be better served by them.
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One specific activity highlighted in the report was a workshop sponsored earlier this summer by the Center for Devices and Radiological Health (CDRH) to formally launch a new program designed to more closely look at medical device use and the health of women (HoW).
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Nearly 200 representatives from industry, academia, health care, federal agencies, patient and advocacy groups, gathered to discuss the issues related to medical devices and health in women and to brainstorm about effective strategies to address clinical research needs in this population.

This work builds on a December 2011 draft guidance, also highlighted in this month’s 907 report.'

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