Diving brief:

  • The FDA’s Center for Devices and Radiological Health on Tuesday released a finalized strategic plan to address sex and gender-specific issues in the design and performance of medical technologies, including improving collection and analysis. Datas. The effort targets both devices developed specifically for women and those designed for people of all sexes and genders.
  • The agency stressed the importance of representation in biomedical research, noting that historically, clinical studies have overwhelmingly been conducted in patients designated as male at birth. “A lack of representation can have serious consequences for women’s health,” said Terri Cornelison, director of CDRH’s Women’s Health Program, in a statement announcing the release of the document.
  • CDRH released a proposed version of the strategic plan for women’s health in September 2019 and solicited feedback from the public and other stakeholders before releasing the final version.

Overview of the dive:

The plan follows several high-profile product safety issues regarding medical devices specific to women’s health. For example, tThe agency has taken steps such as restricting sales of breast implants due to a potential link to cancer and stopping the use of surgical mesh devices for transvaginal repair of pelvic organ prolapse after that thousands of women have reported serious complications.

The new Strategic Plan for Women’s Health Surveillance identifies improving processes for early identification and communication of adverse effects of devices on women as one of its three main goals. “We plan to strengthen our approach in how we, as a center, probe, identify, scientifically assess, track, prioritize, address and report on current and emerging issues related to women’s health,” the document states.

CDRH said it intends to seek partners in academia, other federal agencies, industry, private foundations, patient advocacy groups and international organizations to explore initiatives to support research and innovation in medical technologies to improve women’s health.

Two other priorities in the centre’s plan focus on data. The agency said it would seek to modernize its policies to account for the inclusion and assessment of medical device data representing demographic subgroups, including sex- and gender-specific data.

An approach emphasizing analysis and reporting of sex- and gender-specific data could inform device submission recommendations, CDRH said. Reporting sex and gender data has the potential to aid in the development of safer and more effective devices, help minimize adverse events in women, and help CDRH improve surveillance and detection. signals, the FDA said.

The plan also aims to develop a research roadmap to identify gaps and unmet needs related to women’s health. The agency wants to work with its customers to create device registries for women and facilitate sex and gender analyzes and expects the data to improve recommendations on the design of clinical trial devices.