Real-Time Post-Market Signal For Enhanced Surveillance

The U.S. Food and Drug Administration (FDA), through its Office of Acquisition and Grant Services, is conducting market research to identify real-time or near-real-time signal generation capabilities to support post-market surveillance activities for FDA-regulated products including drugs, biologics, medical devices, vaccines, food, cosmetics, and veterinary products. This Request for Information (RFI) seeks to understand whether commercial organizations currently provide or could provide timely signals and alerts related to safety events, product quality issues, supply disruptions, compliance actions, and other significant public health signals. Key requirements include demonstrating organizational capabilities, describing types of signals and data sources with update frequencies, explaining signal detection and validation methodologies, detailing technical integration approaches (particularly API architectures), documenting security and privacy compliance practices (HIPAA, NIST, FISMA), and providing rough order of magnitude pricing for various models. The FDA emphasized that it seeks earlier detection of safety signals—ideally within a 24-hour window—to shift from reactive to proactive surveillance, and evaluation will focus on the ability to deliver minimal necessary data in aggregated or summarized format rather than full platform systems. RFI responses are due electronically by April 7, 2026, at 10:00 AM ET, with an optional Vendor Day held on April 1, 2026, from 12:00 PM to 2:00 PM Eastern Time (registration deadline March 26, 2026).

This RFI is issued for market research purposes only and does not constitute a solicitation for proposals or a commitment by the Government to issue a future solicitation, meaning no set-aside designations apply and no award values are specified at this stage. The FDA has not identified any incumbent contractors or preferred vendors and explicitly anticipates engaging multiple vendors rather than a single provider to support its enhanced surveillance objectives. No specific budget ranges or contract values are disclosed in this pre-solicitation notice, as the RFI is designed to gather competitive intelligence regarding industry capabilities, technical approaches, and potential cost models before determining acquisition strategy. Respondents must limit RFI submissions to 15 pages and must include organizational information such as UEI, DUNS number, CAGE code, SBA size designation, employee count, and annual receipts. The Government reserves the right to use submitted information for market research and acquisition planning purposes with no obligation to acknowledge receipt or provide feedback on RFI responses.