The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has released its Health of Women Program Strategic Plan, which lays out a plan to protect and promote women’s health by strengthening regulatory science and identifying and addressing current and emerging issues in Medical Device research and regulation for the benefit of all women.
While sex and gender are related, they are not always mutually exclusive, and their interactions can have an impact on physiological reactions, disease presentation, and treatment outcomes. The CDRH Health of Women initiative was established in 2016 to address sex and gender-related concerns that arise from medical technology development, clinical trial design, and other Medical Device-related difficulties.
Cardiovascular devices such as pacemakers, for example, may have differing outcomes and complication rates in men and women. This is only one example of how gender and sex have a role in developing a clinical trial that will yield the best results in terms of safety and effectiveness for all patients. The CDRH Health of Women Program developed its strategic plan in 2019 with the premise that sex and gender differences play a role in a person’s unique experience with Medical Device and treatment outcomes.