The FDA has released a new proposed plan to improve medical device safety for women.
The agency’s Center for Devices and Radiological Health (CDRH) said today that the proposed strategic plan will address sex- and gender-specific issues in medtech design, development, clinical trial design and other medical device-related matters.
The strategic plan is part of 2016 CDRH’s Health of Women program, designed to consider a woman’s entire body — not just her reproductive system.
The plan sets three general priorities:
- Improve collection, availability, analysis, and communication of sex- and gender-specific information for the safe and effective use of medical devices and performance of medical devices in women, and ensure that CDRH policies evolve with current science.
- Strengthen CDRH health science programs, integrate analyses of women’s health issues, explore innovative strategies, technologies and device-specific study models and improve outreach.
- Develop a “research roadmap” for issues that affect women’s health, addressing gaps and unmet needs and promoting regulatory science advancement as it relates to women’s health.
“We seek 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,” the plan says.
The FDA has been under fire for years for allowing the sale of certain devices for women, such as pelvic mesh and breast implants, that have been blamed for causing injuries, illnesses and deaths. Medtech companies have paid millions of dollars in legal settlements over these devices, and litigation is ongoing.
CDRH is seeking input on the proposed strategic plan, which may be found here.