Research & Education of Medical Device Countermeasure Development & Availability

Public Law 113-5 (also known as the Pandemic and All-Hazards Preparendess Reauthorization Act) contains legal authorities to sustain and strengthen our Nation's preparedness for public health emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, as well as emerging infectious disease threats. It's provisions further FDA's mission of fostering the development and availability of medical countermeasures devices in emergencies through funding of regulatory science, site visits, reviewer education and training, and enhanced review processes. These MCM efforts also support Public Law 115-2 which enables FDA to authorize additional emergucency uses for medical devices to reduce deaths and severity of injuries caused by biological, chemical, radiological or nuclear (CBRN) agents or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to the U.S. military forces and for other purposes