SPADA Docs

authorization, fact sheets, and other documentation needed for an EUA in advance of an 788 emergency and also helps to facilitate completion of an EUA request during a current emergency 789 declaration. Note that a pre-EUA can only transition to an EUA if there is a current applicable 790 emergency declaration. Additional information on how to submit a pre-EUA for In Vitro 791 Diagnostics to FDA can be found at the corresponding page at FDA’s website (39). 792 During the effective period of the HHS Secretary's EUA declaration, FDA may authorize the 793 introduction of a medical product into interstate commerce to be used in an emergency to 794 diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN 795 threat agents when there are no adequate, approved, and available alternatives, provided that 796 certain statutory criteria are met. When deciding whether to issue an EUA for a specific medical 797 product, FDA determines whether the known and potential benefits of the product outweigh the 798 known and potential risks based on the totality of the scientific evidence at the time of the EUA 799 request. The EUA authority facilitates the availability and use of MCMs needed to prepare for 800 and respond to public health emergencies. When an EUA declaration is terminated by the HHS 801 Secretary, then any EUA(s) issued based on that declaration will no longer remain in effect and 802 can therefore no longer be marketed.

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7.2 FDA Regulatory Pathways

The overall objective for medical device manufacturers (i.e. assay developers) is to 806 demonstrate reasonable assurance of safety and effectiveness to FDA prior to introducing a 807 medical device into interstate commerce. The following is general information on FDA 808 regulation of medical devices. This discussion is intended as an introduction to medical device 809 development and regulatory review. FDA encourages sponsors to utilize the optional pre- 810

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