SPADA Draft Documents

During the effective period of the HHS Secretary's EUA declaration, FDA may authorize the 732 introduction of a medical product into interstate commerce to be used in an emergency to 733 diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, 734 biological, radiological, and nuclear (CBRN) threat agents when there are no adequate, 735 approved, and available alternatives, provided that certain statutory criteria are met. When 736 deciding whether to issue an EUA for a specific medical product, FDA determines whether the 737 known and potential benefits of the product outweigh the known and potential risks based on the 738 totality of the scientific evidence at the time of the EUA request. The EUA authority facilitates 739 the availability and use of MCMs needed to prepare for and respond to public health 740 emergencies. When an EUA declaration is terminated by the HHS Secretary, then any EUA(s) 741 issued based on that declaration will no longer remain in effect and can therefore no longer be 742 marketed. 746 demonstrate reasonable assurance of safety and effectiveness to FDA prior to introducing a 747 medical device into interstate commerce. The following is general information on FDA 748 regulation of medical devices. This discussion is intended as an introduction to medical device 749 development and regulatory review. FDA encourages sponsors to utilize the optional pre- 750 submission program in which they can submit requests for FDA feedback on any concerns (e.g., 751 clinical trial design) or to discuss specifics that may pertain to the appropriate regulatory 752 pathway for their device (38). As a rule, early discussions such as those through the pre- 753 submission feedback mechanism facilitate agreement on items such as appropriate validation 754 743 744 FDA Regulatory Pathways 745 The overall objective for medical device manufacturers (i.e. assay developers) is to

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