Real-Time Post-Market Signal For Enhanced Surveillance

The U.S. Food and Drug Administration (FDA) is conducting market research to better understand industry capabilities related to providing real-time or near-real-time signals that may support FDAs post-market surveillance activities for regulated products. FDA is interested in learning whether commercial organizations currently provide, or could provide, timely signals or alerts related to events affecting regulated products, such as safety events, product quality issues, supply disruptions, or other significant public health signals. Information obtained through this Request for Information (RFI) will assist the Government in determining the availability of industry capabilities, potential technical integration approaches, and possible cost models associated with providing real-time signal