SPADA Docs

The following is a general overview on the types of regulatory submissions a Sponsor can 765 prepare for a medical device, and is intended to serve as an introduction on how their device (i.e., 766 a molecular assay or IVD that is within the scope of this document) can be regulated. FDA 767 encourages Sponsors to participate in the optional pre-submission process if they have specific 768 questions that they wish to be addressed by the agency on their medical device. Further 769 information on the pre-submission process is provided below. 770 7.1 Emergency Use Authorization (EUA) Authority 771 Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (37), the FDA 772 Commissioner may authorize the emergency use of unapproved medical products or unapproved 773 uses of approved medical products for certain emergency circumstances. Before FDA may issue 774 an EUA, the Health and Human Services (HHS) Secretary must first declare that circumstances 775 exist justifying the authorization based on one of four determinations made by either the 776 Secretary of Homeland Security, the Secretary of Defense or the Secretary of HHS of a material 777 threat, an actual emergency or a significant potential emergency involving a Chemical, 778 Biological, Radiological and Nuclear (CBRN) agent or agents, or a disease or condition that may 779 be attributable to such agent(s). More information can be found in the FDA finalized guidance— 780 "Emergency Use Authorization of Medical Products and Related Authorities” (38). 781 To help prepare for potential and current emergencies, FDA works with medical 782 countermeasure (MCM) developers to prepare Pre-EUA packages, when appropriate. A Pre- 783 EUA package contains data and information about the safety, quality, and efficacy of the 784 product, its intended use under a future or current EUA, and information about the emergency or 785 potential emergency situation. The pre-EUA process allows FDA technical subject matter 786 experts to begin reviewing information and assist in the development of conditions of 787

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