SPADA Meeting Book

During the effective period of the HHS Secretary's EUA declaration, FDA may authorize the 753 introduction of a medical product into interstate commerce to be used in an emergency to 754 diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN 755 threat agents when there are no adequate, approved, and available alternatives, provided that 756 certain statutory criteria are met. When deciding whether to issue an EUA for a specific medical 757 product, FDA determines whether the known and potential benefits of the product outweigh the 758 known and potential risks based on the totality of the scientific evidence at the time of the EUA 759 request. The EUA authority facilitates the availability and use of MCMs needed to prepare for 760 and respond to public health emergencies. When an EUA declaration is terminated by the HHS 761 Secretary, then any EUA(s) issued based on that declaration will no longer remain in effect and 762 can therefore no longer be marketed. 766 demonstrate reasonable assurance of safety and effectiveness to FDA prior to introducing a 767 medical device into interstate commerce. The following is general information on FDA 768 regulation of medical devices. This discussion is intended as an introduction to medical device 769 development and regulatory review. FDA encourages sponsors to utilize the optional pre- 770 submission program in which they can submit requests for FDA feedback on any concerns (e.g., 771 clinical trial design) or to discuss specifics that may pertain to the appropriate regulatory 772 pathway for their device (38). As a rule, early discussions such as those through the pre- 773 submission feedback mechanism facilitate agreement on items such as appropriate validation 774 763 764 7.2 FDA Regulatory Pathways 765 The overall objective for medical device manufacturers (i.e. assay developers) is to

Commented [LN(20]: Only HHS here? Or also DOD and  DHS?  Commented [SS21R20]: Soong 

Commented [LN(22]: Only HHS?  See above comment  Commented [SS23R22]: Soong

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