By: Michelle McMurry-Heath, MD, Ph.D.
Women differ from men in anatomy, physiology, risk factors and disease symptoms. They are also likely to use more medical devices over the course of their lives than men do.
That is why FDA is actively trying to learn more about how medical devices uniquely affect women, and how women can be better served by them.
This month we published a snapshot of how FDA is doing with such efforts. A congressionally-required report (Section 907 of the Food and Drug Administration Safety and Innovation Act) looked at the inclusion and analysis of women and other demographic subgroups in clinical studies supporting the approval of medical devices and other FDA-regulated medical products. After reviewing 2011 product applications, including 37 premarket approval applications, or PMAs, for devices, we found that in the majority of cases, sponsors provide information about women, conduct subset analyses and share information with the public in a variety of ways.
One specific activity highlighted in the report was a workshop sponsored earlier this summer by the Center for Devices and Radiological Health (CDRH) to formally launch a new program designed to more closely look at medical device use and the health of women (HoW). The three main goals of HoW are to:
- Improve the availability, consistency and communication of information to patients and providers that is specific to women’s needs for the safe and effective use of medical devices.
- Address identified gaps and unmet needs through targeted resources.
- Foster the development of innovative strategies, technology and clinical study models.
Nearly 200 representatives from industry, academia, health care, federal agencies, patient and advocacy groups, gathered to discuss the issues related to medical devices and health in women and to brainstorm about effective strategies to address clinical research needs in this population.
This work builds on a December 2011 draft guidance, also highlighted in this month’s 907 report. That guidance outlined CDRH’s proposed expectations regarding sex-specific enrollment in clinical studies, data analysis, and reporting of study information. Ideally, the final guidance will provide a clear decision-making framework for when and how to analyze and communicate data involving women in device clinical studies.
The CDRH HoW program also plans to complement this by developing, in partnership with other stakeholders, strategies for communicating information about differences to the people who most need to know: health care professionals, clinical investigators, the medical device industry, and most importantly, patients.
With these activities, we are laying the groundwork for making sure the unique health needs of women are considered in research agendas and device innovation. The goal is to strengthen the focus of FDA, industry and the clinical community in developing medical devices designed to meet the unique clinical needs of women, and to communicate new information as we learn more about how differences affect treatment options and outcomes.
Now, with the issuance of the 907 report, and an accompanying docket to receive comments from the public, we hope to gain an even more in-depth understanding about demographic subgroups. The input we receive will become the starting point for developing an Action Plan, to be released next year.
These are all important steps towards ensuring that medical devices developed will take into account the unique needs of women.