SPADA Draft Documents

Creation of data and documentation for regulatory reviews

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Emergency Use Authorization (EUA) Authority

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Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (35), the FDA 711 Commissioner may authorize the emergency use of unapproved medical products or unapproved 712 uses of approved medical products for certain emergency circumstances. Before FDA may issue 713 an EUA, the HHS Secretary must first declare that circumstances exist justifying the 714 authorization based on one of four determinations made by either the Secretary of Homeland 715 Security, the Secretary of Defense or the Secretary of HHS of a material threat, an actual 716 emergency or a significant potential emergency involving a CBRN agent or agents, or a disease 717 or condition that may be attributable to such agent(s). More information can be found in the FDA 718 finalized guidance—"Emergency Use Authorization of Medical Products and Related 719 Authorities” (36). 720 To help prepare for potential and current emergencies, FDA works with medical 721 countermeasure (MCM) developers to prepare Pre-EUA packages, when appropriate. A Pre- 722 EUA package contains data and information about the safety, quality, and efficacy of the 723 product, its intended use under a future or current EUA, and information about the emergency or 724 potential emergency situation. The pre-EUA process allows FDA technical subject matter 725 experts to begin reviewing information and assist in the development of conditions of 726 authorization, fact sheets, and other documentation needed for an EUA in advance of an 727 emergency and also helps to facilitate completion of an EUA request during a current emergency 728 declaration. Note that a pre-EUA can only transition to an EUA if there is a current applicable 729 emergency declaration. Additional information on how to submit a pre-EUA for In Vitro 730 Diagnostics to FDA can be found at the corresponding page at FDA’s website (37). 731

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