By Matt Walker, recall advisor
The US Food and Drug Administration (FDA) has turned its attention to the development and regulation of medical devices unique to women’s health.
The FDA’s Center for Devices and Radiological Health (CDRH) recently finalized its Health of Women Program Strategic Plan. The plan, initially proposed in September 2019, looks to protect and promote the health of women, strengthen regulatory science and identify and address current and emerging issues in medical device research and regulation.
We noted in a previous blog that epidemiologists represent the driving force behind improving women’s health. The evolution is driven by the premise that people of different biological sexes have unique responses to disease, medications, therapies and medical devices. The concept is increasingly understood, but only recently changing the way regulators and companies identify sex-related safety signals in medical devices.
According to the CDRH, historically, biomedical research has been primarily focused on male subjects. In fact, 88 percent of research for diseases more prevalent in females was conducted on male subjects. The agency claims that in many cases, current data may be incomplete because of the lack of female representation in the studies.
While there are no regulations or guidance yet around this new initiative, medical device manufacturers should begin to look at the mix of males and females in their testing and ensure that sex and gender data are part of their analysis and reporting.
The finalized strategic plan sets out a portfolio of women-specific device efforts and strategies to close research gaps. It has three key priorities:
- Sex- and gender-specific analysis & reporting – Improve availability, analysis and communication of sex- and gender-specific information for the safe and effective use of medical devices to improve and better understand the performance in women; optimize CDRH practices for consistent sex- and gender-specific data collection, analysis and reporting; ensure CDRH’s policies evolve with current science.
- Integrated approach for current & emerging issues related to the health of women – Strengthen internal health science programs and initiatives across CDRH to create actions that aim to improve the overall health and quality of life for women; coordinate and lead an integrated approach to analyze current and emerging issues related to the health of women; explore innovative strategies, technologies and device-specific study paradigms; develop center-wide policies and outreach activities related to the health of women.
- Research roadmap – Develop a guide for navigating the health of women’s medical device ecosystem; address identified gaps and unmet needs related to the health of women through targeted resources; promote advancement of regulatory science related to the health of women.
We can expect further shifts in medical-device regulation with regard to women’s health. By staying up-to-date on this development now, companies can ensure they will remain compliant with FDA regulations, and that all consumers are safe when using their devices.
Trusted by the world’s leading brands, Sedgwick has managed more than 5,000 of the most time-critical and sensitive product recalls in 60+ countries and 20+ languages, over 25 years. To find out more about our experience within the medical device industry, visit our website.