The U.S. Food and Drug Administration (FDA) is seeking public comment on a draft guidance intended to define expectations about inclusion of women* in medical device research, including making sure women are represented in clinical trials and that data on women’s outcomes with devices should be collected and reported. Medical devices include products like lenses, coronary stents and pacemakers, breast and hip implants, prostheses, and other equipment for diagnosis and therapy.
The FDA is the agency that approves medical devices for use/marketing in the United States, so we would expect them to ask about these issues and data when companies propose that a device be approved.
This is meant to improve how risks and benefits of medical devices can be understood and communicated to women, and to encourage researchers to consider how sex-related differences may affect women’s outcomes when using medical devices.
For example, according to an evaluation of studies used to seek approval for heart-related devices, there was “persistent underrepresentation” of women – only about 1/3 of the study participants were women. Studies of certain existing heart devices have already found increased risks of adverse effects in women for some products, and possible better outcomes for women using some other devices.
Comments are due before midnight (Eastern time) on March 12, 2012. They can be submitted online, or via mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. If you write a paper letter, you should include the docket number: FDA-2011-D-0817.
*Note: the language used in the FDA documents defines female sex “according to their reproductive organs and functions assigned by chromosomal complement,” and gender as provided by patient/participant self-report.