FDA, Veterans Health Administration Partner to Accelerate Medical Device Innovation
WASHINGTON — The Food and Drug Administration and the Veterans Health Administration have entered into a new level of collaboration intended to help accelerate American medical device innovation.
Under the auspices of a memorandum of understanding signed last week, the VA Ventures Innovation Institute in Seattle, Washington, will host up to 12 FDA staff “to foster robust collaborations between the agencies,” a joint press release says.
While there, the FDA staff will focus on regulatory science — the science for evaluating the benefits and risks of new products — and VA staff will provide clinical context for test development and provide hands-on training and other immersive experiences for innovators wishing to utilize the tools.
“Both the FDA and VA need to stay at the forefront of new medical technology development, and the science of evaluating new technology,” said Dr. Jeff Shuren, J.D., director of the FDA’s Center for Devices and Radiological Health.
“This strategic alignment between our organizations creates a unique environment to achieve shared objectives for accelerating patient access to safe, innovative and effective medical devices,” he said.
Together, the organizations will work toward developing and disseminating new tools designed to test the safety and effectiveness of medical devices and emerging technologies.
These “off-the-shelf” testing tools will provide innovators with straightforward, reproducible and cost-effective testing methods throughout the product development cycle.
Providing standardized tests can help streamline the regulatory evaluation process, accelerating the time it takes for products to reach patients by increasing predictability in the product development process.
This effort may also reduce risks for early innovators that might not have access to more elaborate testing systems, the agencies said.
Dr. Shereef Elnahal, VA’s under secretary for Health, said by working side by side, the agencies will be able to leverage their combined strengths and bring the most promising health care technology innovations to market “faster than ever before.”
“Additionally, the co-location in Seattle will allow us to tap into important health care-adjacent technology markets,” Elnahal said.