FDA to Collaborate with Veterans group on Medical Device Innovation
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On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures Innovation Institute. According to the FDA, the intent of the collaboration is to “help accelerate American medical device innovation to further improve and benefit public health. One goal of the collaboration is providing innovators with “straightforward, reproducible, and cost-effective testing methods throughout the product development cycle.”
Jeff Shuren, M.D., J.D., the director of the FDA’s Center for Devices and Radiological Health stated in the FDA’s announcement of the collaboration that:
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.
The VHA will host staff from the FDA at the VA Ventures Innovation Institute in Seattle. According to the announcement, the FDA staff will be focused on the regulatory science while the VA staff will provide “clinical context for test development and provide hands-on training and other immersive experiences.”
The initial collaboration is described by the FDA as focusing on systems which can “exchange health information automatically for the diagnosis and treatment of patients.” While future areas of collaboration may include “the development of test methods for devices that can be used at a distance through, for example, 5G networks.”
Dr. Shereef Elnahal, the VA’s Under Secretary for Health, stated in the FDA announcement:
By working side by side, VA and FDA will leverage our combined strengths and expertise to bring the most promising health care technology innovation to Veterans – and Americans at large – faster than before.
The announcement by the FDA is available here.
Paige Cappelli primarily focuses on patent prosecution and patent litigation in the mechanical and medical device areas.
Paige graduated magna cum laude from Temple University Beasley School of Law. While attending Temple University, Paige served as President of the Intellectual Property Law Society. Prior to law school, Paige received her BS in Industrial Engineering from California Polytechnic State University, San Luis Obispo.
Paige worked as a summer associate at the firm in 2019 and joined the firm in 2021.
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