On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement  Public Law 115-92, which was enacted in 2017.  The law gives the DoD new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products that could help protect and treat U.S. military forces; we analyzed that legislation in a blog post here.

Perhaps more significantly, FDA has chosen to build on the new law to facilitate development and FDA review of medical products with military applications that may also have broader use for general populations.  In FDA’s initial Work Plan for the new law, FDA committed to issue guidance to facilitate development of medical products for “austere environments” relevant to the military.  In fact, the Work Plan states that the guidance will “include information on how the approval can be expanded to the general population, when relevant.  The latter is important for the ultimate availability and sustainability of the DoD medical product development enterprise.”

Under the terms of this MoU: