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. I will not discuss off label use and/or investigational use of the following drugs/devices in my presentation:I do not have any relationship(s) to disclose.. Interagency Registry for Mechanically Assisted Circulatory SupportNHLBI Contract
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27. Adverse Event Collection Adverse Events: Data on specific adverse events will be collected by two mechanisms:
(1) The occurrence of infection, device failure, neurological event, and death trigger a separate screen which will collect relevant data elements;
(2) Other adverse events will be identified and collected through routine data acquisition at the specified follow-up intervals
31. Relevance to FDA (and therefore Industry) Standardized adverse event definitions
Manufacturers and user facilities must fulfill their own specific reporting requirements and this can occur through their participation in INTERMACS
FDA letters to user facilities exempt them from MDR reporting if they participate in INTERMACS; however devices not collected by INTERMACS must follow current MDR reporting process
INTERMACS data will be helpful for manufacturers as they develop other clinical trial designs
