In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests. 

In early September, FDA released their strategic plan for the Health of Women Program, a program within the Center for Devices and Radiological Health (CDRH) that aims to explore the unique issues related to the performance of medical devices in women.

The 41-page document outlines the agency’s mission, vision, and efforts to better understand and address the impact of sex- and gender-specific issues on medical technology design and development, clinical and non-clinical study design, and other medical device-related matters. This is a huge win for women who are patients…so this pretty much means ALL women (US and abroad) should hopefully benefit!

For years, both FDA and the scientific community have been aware that sex and gender can play a significant role in the course and outcome of conditions that affect all organ systems. The agency states that the Health of Women Program will address “health conditions that are specific to women, as well as conditions that are more common or more serious in women, have distinct causes or manifestations in women, have different outcomes or treatment options in women, or have higher morbidity or mortality in women”.

Evidence shows that sex and gender can impact numerous disorders, including cardiovascular disease, pulmonary dysfunction, neurological debility, irritable bowel syndrome, endocrine and autoimmune disorders, and mental illness. The program’s vision is to ensure that, “patients, caregivers, and providers have timely access to high quality, safe, and effective medical devices that perform optimally in women, as well as access to relevant and understandable sex- and gender-specific information about medical devices that can be used to make informed health care decisions”.

The CDRH Health of Women Program has initially prioritized three focus areas:

  1. Sex- and gender-specific analysis & reporting

  2. An integrated approach for current & emerging issues related to the health of women

  3. A research roadmap

With regard to sex- and gender-specific analysis and reporting, FDA intends to improve the availability, analysis, and communication of sex- and gender-specific information for the safe and effective use of medical devices. The goal is to improve and better understand the performance of medical devices in women. The Health of Women Program also aims to build and strengthen programs and initiatives across CDRH to improve the overall health and quality of life for women. The plan is to bring together CDRH offices, device manufacturers, scientists and patients in order to coordinate and develop an integrated approach to deal with current and emerging women’s health issues. Finally, FDA has made it clear that the program will support the development of a research roadmap to identify and address gaps and unmet needs, as well as promote regulatory science, as it relates to the health of women.

The strategic plan for the Health of Women Program aims to “bring together industry, clinicians, researchers, patients, academia, government agencies, advocacy groups, and all customers in an effort to encourage innovations in research study design, device development, and appropriate ways to share information with women and their health care providers to help them make informed decisions about which device may best meet their needs.”

In addition to introducing the CDRH Health of Women Program and detailing the framework by which the program will address the steadily growing importance of women’s health, the strategy document provides several additional, thoughtful sections detailing the scientific rational behind the program. In the appendix, the document discusses the history of male predominance in research, the fact that sex is a basic biological variable, and how gender is a clinical variable. The CDRH Health of Women Program Strategic Plan recognizes the importance of addressing sex- and gender-specific issues in medical technology design, development and implementation, and details the program’s plans to provide the highest quality of innovation, safety, and effectiveness to every patient.

The CDRH Health of Women Program welcomes comments and feedback on the outlined Strategic Plan, and encourages other ideas and suggestions on how they can strengthen the collection and dissemination of information associated with sex and gender related devices.

Comments and feedback can be sent to docket number FDA-2019-N-3804 in the Federal Register.

You can also send your questions about CDRH’s Health of Women Program to:

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