Today the FDA and the Department of Defense (DoD) announced a joint program to prioritize the development of medical devices for military personnel, including to treat injuries on the battlefield. The FDA will work with Health Affairs to understand what the military needs for deployed personnel and will expedite the review of priority DoD medical products similar to the process under the breakthrough designation program. The FDA will also give technical advice to the DoD’s Office of Health Affairs to enable faster development and manufacturing of devices that the U.S. military can use.
The outline for the program came together through H.R. 4374, which was enacted in December 2017 with the National Defense Authorization Act for FY 2018.
“The initial program will ultimately allow us to implement a robust and enduring pathway across the entire agency to expedite access to such products as we fulfill our commitment to our Nation’s warfighters.” – Anna Abram, FDA
The first phase of the program will be conducted with CBER, as current DoD product programs place high priority on freeze-dried plasma, cold-stored platelets and cryopreserved platelets.
This year FDA and the DoD’s Office of Health Affairs will hold workshops to discuss scientific and clinical product development that is relevant to military personnel. The agency will also release a guidance document to assist product developers in finding opportunities that fulfill unmet medical needs on the battlefield and the frontlines.