Inactive

The purpose of this requirement is to award a research and development (R&D) contract for an FDA approved, Soldier-wearable device that will meet the U.S. Military needs to prevent brain injuries and ... The purpose of this requirement is to award a research and development (R&D) contract for an FDA approved, Soldier-wearable device that will meet the U.S. Military needs to prevent brain injuries and maintain the safety and performance by those exposed to potentially concussive events including, but not limited to, blast pressure waves generated by missiles, improvised explosive devices; occupational exposure to overpressures from relevant weapon systems (ex. breaching charges, outgoing mortars/artillery, and shoulder-launched weapons); and impact by an object. To meet the Military need, the prototype and eventually the final marketed production device will possess, at a minimum, the threshold attributes and eventually meet the objective attributes stipulated in Section 1. The vendor will perform and be responsible for any and all research and development activities, manufacture, compliance with applicable FDA regulations including 21 Code of Federal Regulations (CFR) Part 312 sub-part D (as it pertains to FDA-Sponsorship of clinical trials), and will be expected to serve as the sponsor for device submission to the FDA for pre-market approval of the device for the intended use/indication for use. The vendor will produce prototype devices and test and production representative devices for limited user testing. The vendor shall develop the device in accordance with all applicable State laws, Federal laws, Department of Defense (DoD) regulations, and U.S. Army regulations. Aim 1 will accomplish the research and development of a device with the stipulated attributes, and production of prototype devices to be assessed in limited user testing and environmental resilience testing.