FDA’s Center for Devices and Radiological Health https://www.fda.gov and the Veterans Health Administration (VHA) are collaborating to accelerate U.S. medical device innovation.
The organizations will develop and disseminate new tools to test the safety and effectiveness of medical devices and emerging technologies.
VA’s Ventures Innovation Institute, https://www.innovation.va.gov/ecosystem/home.html in Seattle, will host up to 12 FDA staff to foster collaborations between the two agencies. FDA will focus on regulatory science while the VA will focus on providing clinical context for test development and provide hands-on training for innovators wishing to utilize the tools.
Providing standardized tests will help streamline the regulatory evaluation process by accelerating the time it takes for products to reach patients by increasing predictability in the product development process.
An increasing number of medical devices, such as ventilators and fluid resuscitation systems, will be controlled autonomously based on inputs from a variety of sensors. Ensuring appropriate function of both the sensors and the systems is a vital goal for this emerging area. Future areas for collaboration will include the development of test methods for devices that can be used at a distance such as 5G networks.