FDA Medical Device Framework with New Improvements

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.

It has sought to advance understanding of how Medical Device designed specifically for women and for individuals of all sexes and genders perform in women since its creation. It is to investigate the unique challenges in the regulation of linked to women’s health. Preclinical cell research, animal studies, and clinical research have all traditionally been done on patients who were born male. Understanding how medical products, particularly Medical Device, interact with people of diverse sexes and genders requires representation in study. Women’s health results can be adversely affected by a lack of representation.

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.