The FDA is pushing for medical technology companies to do a better job including women and people of diverse gender identities when testing new medical devices. The agency’s new guidance calls for companies to think more carefully about sex and gender differences when designing their studies, make sure they’re recruiting a diverse mix of participants, and properly analyze and report how their devices work for different groups. While companies don’t legally have to follow these recommendations yet, they represent what the FDA believes is the right approach to ensure medical devices are safe and effective for everyone who might use them.
This update comes after decades of women being left out of medical research, which has meant doctors and patients often lack accurate information about whether devices and drugs work as well for women as they do for men. The FDA points out that many groups have been historically excluded from these studies, including transgender and nonbinary individuals. Multiple barriers have contributed to this underrepresentation, including fewer opportunities for participation, concerns about fertility and pregnancy risks, family responsibilities limiting trial commitment, and selection criteria that unintentionally exclude certain demographics. Though more women are being included in medical device studies than ever before, the FDA says most areas of medicine still need to achieve better representation.
Advocates have been calling for more guidance from the FDA for years, which The Fuller Project has chronicled in our medical research series. For example:
In Sex Matters: Medical Research Overlooks Women, Maggie Fox offered a status report on medical research about women three decades after Congress ordered the NIH to include women in clinical trials at the same rates as men. The update? Research on women still lags, and women and girls are paying the price with their health and their lives.
In Why Heart Disease Research Still Favors Men, Fox reported that while men and women are equally likely to suffer heart attacks, women are more likely to die from theirs, one of the many symptoms of the medical system’s neglect of women.
In ‘My community is still dying’ — How the dearth of Black women in clinical research worsens health disparities, Erica Hensley reported that by 2020, there was just one Black woman for every 10 white women in FDA-approved drug trials, despite Black women being more likely to be diagnosed late and die from female-specific diseases, like breast, ovarian and cervical cancer.
Hensley’s story, New federal report calls out clinical trials for excluding pregnant women highlighted the lack of medications on the market that have been tested for safety and efficacy in pregnant women, and looked at an influential federal panel that is challenging the unspoken rules of excluding pregnant women from clinical trials.
