Real-Time Post-Market Signal For Enhanced Surveillance
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA) is conducting market research through a Request for Information (RFI) to understand industry capabilities for providing real-time or near-real-time post-market signals for regulated products. This RFI aims to identify potential solutions for enhanced surveillance related to safety events, product quality issues, supply disruptions, and public health signals. Responses are due by April 7, 2026, at 10:00 AM ET.
Purpose & Scope
The FDA seeks to learn whether commercial organizations currently provide, or could provide, timely signals or alerts affecting regulated products. Information gathered will assist the Government in determining the availability of industry capabilities, potential technical integration approaches, and possible cost models for delivering real-time signal feeds to FDA systems. This is for market research only and does not constitute a solicitation.
Key Areas of Interest
- Signal Types: Safety events, product quality issues, supply disruptions, public health alerts, compliance, or regulatory actions.
- Data Sources: Information on data sources used to generate signals.
- Technical Integration: Approaches for signal delivery, including APIs (REST, streaming, webhooks), data formats, and integration models (push vs. pull).
- Security & Privacy: Practices for data protection and compliance with standards (HIPAA, NIST, FISMA).
- Cost Information: Potential pricing approaches (subscription, transaction-based, volume-based) and implementation costs.
Submission Requirements
- Responses should not exceed 15 pages.
- Address organizational overview, signal types and sources, signal detection and validation, technical integration, security and privacy, and relevant experience.
Contract & Timeline
- Type: Request for Information (RFI) / Market Research
- Set-Aside: None specified (market research stage)
- Response Due: April 7, 2026, at 10:00 AM ET
- Published: March 18, 2026
Additional Notes
- The FDA will host a virtual Vendor Day on April 1, 2026, from 12:00 PM to 2:00 PM ET. Registration requests are due by March 26, 2026, at 10:00 AM ET.
- This RFI is for market research only and does not obligate the Government to award a contract or pay for information provided. Participation does not guarantee future procurement involvement.