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 FDA's post-market surveillance activities for regulated products. The 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. Some key points to consider include: • The FDA is looking for signals that can be delivered through Application Programming Interfaces (APIs) or other automated integration mechanisms. • The signals of interest may include safety events, product recalls, manufacturing disruptions, supply chain shortages, and public health alerts. • The FDA is interested in understanding whether such signals could be delivered to FDA systems through APIs or other automated integration mechanisms. • The FDA welcomes information regarding innovative signal types, including signals derived from digital sources, advanced analytics, or machine learning methods.