FDA Seeks to Improve Medical Devices for Women

Clinical trial sponsors must step up their efforts to address underrepresentation of women among subjects in clinical trials, including for medical devices, said FDA Commissioner Scott Gottlieb during a meeting to commemorate National Women’s Health Week.

Gottlieb said that the agency is making moves to improve the development of safe, women-oriented medical devices. He noted the agency’s initiative to form a registry network, part of the Device Safety Action Plan, which will focus on health technologies that provide more data in women-specific clinical areas like uterine fibroids and pelvic floor disorders.

He also noted the FDA’s initiative to gather real world evidence of device performance, the Women’s Health Technologies Strategically Coordinated Registry Network. Improving analysis and data collection will require the development of common data elements for sex and gender to be included in some prominent medical device registries, he said.