We also recognize that there are some areas where we have real data gaps that we must address. For instance, we need to improve the quality and efficiency of RWE generation for technologies used to address women’s health. As part of the Action Plan we’ve begun building out important registries and establishing the Women’s Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids, pelvic floor disorders, and female long-acting, reversible contraception and sterilization.
Finally, I want to highlight another important issue we’re staying on top of related to device safety: cybersecurity. Like computers and the networks they operate in, medical devices can be vulnerable to security breaches. Exploitation of device vulnerabilities could threaten the health and safety of patients.
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We’ve already taken several steps to promote a multi-stakeholder, multi-faceted approach of vigilance, responsiveness, recovery, and resilience that applies throughout the life cycle of relevant devices. As part of the Action Plan, we’re seeking additional authorities and funding for Congress to consider, which would build on our work to date and further minimize medical device cybersecurity vulnerabilities and exploits. We also intend to seek the authority and funding to develop a CyberMed Safety (Expert) Analysis Board, a public-private partnership that would complement existing device vulnerability coordination and response mechanisms and serve as a resource for device makers and the agency.
Medical device safety is a key priority for the FDA. We’re committed to protecting American patients by minimizing avoidable risks and advancing device technologies that are delivering growing benefits.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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