Real-Time Post-Market Signal For Enhanced Surveillance

Other / Unclassified

This document summarizes a vendor day event held by the FDA to conduct market research for its "Real-Time Post-Market Signal Integration for Enhanced Surveillance" initiative. The event aimed to clarify the intent of a Request for Information (RFI), gather insights on industry capabilities, and shift the FDA's post-market surveillance approach from reactive to proactive and predictive.

Key themes discussed include moving towards real-time signal detection, leveraging diverse external data sources, focusing on early awareness of emerging risks, enabling cross-domain signal correlation, and prioritizing public health impact. The FDA emphasized that they are seeking actionable signals derived from vendor data and analytics capabilities, not full systems or platforms.

This document is crucial for potential bidders as it outlines the FDA's objectives and areas of interest for future procurements related to post-market surveillance. It clarifies:

• Definition of Real-Time: Within approximately 24 hours of signal detection.
• Data Sources: Vendors are expected to leverage their own data sources to detect and send signals to the FDA.
• Signal Types: Interest in both confirmed and emerging signals (early trends).
• Signal Detail: Preference for minimal necessary data, aggregated or summarized signal data, avoiding PII/PHI unless required.
• Delivery Model: Preferred API-based, event-driven signal delivery; not batch uploads or full platform integrations.
• Vendor Role: Detect and submit signals; FDA will perform validation and prioritization.
• Acquisition Strategy: Anticipates multiple vendors, not a single provider. Vendors should propose pricing models.
• Key Takeaways: FDA is building a signal-driven ecosystem, seeking speed, breadth of data, early detection, and actionable insights. Innovation in cross-domain analytics, emerging signal detection, and real-time data processing is encouraged.
• Next Steps: RFI responses are due April 7, 2026, at 10:00 AM. The FDA will continue market research based on these responses.

Other / Unclassified

This document is a presentation from the FDA Vendor Day held on April 1, 2026, focused on "Real-Time Post-Market Signal Integration for Enhanced Surveillance." It outlines the FDA's interest in exploring how real-time or near-real-time signals from industry or external sources can enhance existing post-market surveillance activities.

This event is for planning and information-gathering purposes only and does not constitute a solicitation or commitment by the Government. Key areas of interest for industry input include:

• In-Scope: Understanding industry capabilities for generating real-time signals, identifying available signal types, exploring technical transmission approaches (e.g., APIs), and understanding data sources, timeliness, and validation.
• Out of Scope: Platform development, system build requirements, final acquisition strategy, and vendor-specific solution evaluations.

Signals of interest include safety events/adverse reactions, product recalls/quality issues, manufacturing disruptions, supply chain shortages, public health alerts, and compliance/regulatory actions.

The document also details the agenda, ground rules for the Q&A session, consolidated questions posed by vendors, and next steps, including an RFI response deadline of April 7, 2026.

This information is valuable for potential vendors to understand the FDA's current thinking and potential future needs in post-market surveillance technology and data integration.

Request for Information (RFI)

This RFI is issued by the U.S. Food and Drug Administration (FDA) for market research purposes only. The FDA is seeking to understand industry capabilities in providing real-time or near-real-time signals and alerts related to events affecting FDA-regulated products. This information will help the FDA assess industry capabilities, potential integration approaches, and cost models for delivering such signals to FDA systems. This RFI does not constitute a solicitation for proposals.

• Signal Types: Safety events, product quality issues, supply disruptions, public health alerts, and compliance or regulatory actions.

• Data Sources: Information on the types of data sources used to generate signals.

• Technical Integration: Approaches for delivering signals, including APIs (REST, streaming, webhooks), data formats, and integration models (push vs. pull).

• Security & Privacy: Practices for data protection and compliance with relevant standards (HIPAA, NIST, FISMA).

• Cost Information: Potential pricing approaches (subscription, transaction-based, volume-based) and implementation costs.

• 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.

• Responses are due by April 7, 2026, at 10:00 AM.

• The FDA will host a virtual Vendor Day on April 1, 2026, from 12:00 PM to 2:00 PM (Eastern Time) for additional context and Q&A.

• Registration requests are due by March 26, 2026, at 10:00 AM.

• This RFI is for market research only and does not obligate the Government to award a contract or pay for information provided.

• Participation in this RFI does not guarantee participation in any future procurement.