[20180813]IF10745_紧急使用授权和FDA相关部门.pdf

https:/crsreports.congress.gov Updated August 13, 2018Emergency Use Authorization and FDAs Related AuthoritiesUnder most circumstances, drugs, medical devices, and biologics may only be introduced into interstate commerce if they have been approved, cleared, or licensed by the Food and Drug Administration (FDA). Under certain circumstances, however, FDA may permit a medical product to be provided to patients outside the standard regulatory framework. One of these circumstances is if the Secretary of Health and Human Services (HHS) declares, pursuant to 564 of the Federal Food, Drug, and Cosmetic Act (FFDCA), that an emergency or threat exists due to a chemical, biological, radiologic, or nuclear (CBRN) agent, in which case the HHS Secretary may temporarily authorize the emergency use of an unapproved product or the unapproved use of an approved product. P.L. 115-92, signed into law on December 12, 2017, amended this authority to allow for emergency uses of medical products for threats in addition to CBRN agents, to include agents that may cause or are associated with an imminently life-threatening and specific risk to the United States military. The four-step process required to a