Vendor Day April 2026.pdf

Real-Time Post-Market Signal Integration for Enhanced Surveillance

April 1, 2026

FDA Vendor Day

Agenda

Office of Commissioner April 2026

• 12:00 P.M. to 12:15 P.M. – Welcome

• 12:20 P.M. to 12:45 P.M. – Overview of FDA Post-Market Surveillance Environment

• 12:45 A.M. to 1:45 P.M. – Q&A and Open Discussion

• 1:50 P.M. to 2:00 P.M. – Closing Remarks

Disclaimer: This Vendor Day is for planning and information-gathering purposes only and does not constitute a solicitation or commitment by the Government.

Context and Areas of Interest

Office of Commissioner

FDA is exploring whether real-time or near-real-time signals generated by industry or external sources could complement existing post-market surveillance activities by providing earlier awareness of emerging events affecting regulated products.

In-Scope:

• Understanding industry capabilities for generating real-time signals

• Identifying types of signals currently available in the market

• Exploring technical approaches for signal transmission (e.g., APIs)

• Understanding data sources, timeliness, and validation approaches

Out of Scope:

• Platform development or system build requirements

• Final acquisition strategy or requirements definition

• Vendor-specific solution evaluations

April 2026

Signals of Interest for Industry Input

Office of Commissioner

FDA is interested in learning whether organizations currently provide, or could provide, real-time or near-real-time signals related to events affecting regulated products, including:

April 2026

Ground rules during Q&A

Office of Commissioner April 2026

1) Vendors must identify their name and company name before asking a question. One follow-up question will be allowed if time permits.

2) Each question-and-answer exchange is limited to 2-3 minutes combined. If necessary, the FDA facilitator has the option to cut-off the question.

3) Government will not answer any questions on proprietary information, promise awards, indicate a preferred vendor, discuss source selection criteria in details or reveal budget-sensitive/acquisition-sensitive information.

4) Responses provided during Industry Day do not constitute official answer.

5) FDA representatives will determine which questions can be answered immediately versus those requiring written follow-up, and the government reserves the right to decline answering questions that are premature, inappropriate, or outside the scope.

6) All questions and answers will be shared with all attendees through post-event summaries or in real-time, and the session will be recorded and transcribed for documentation purposes.

7) Q&A content may be incorporated into a Frequently Asked Questions (FAQ) document to provide ongoing guidance to all potential vendors.

8) All Industry Day information, including Q&A content, is provided for general guidance only and does not amend or modify the official solicitation document, with unanswered questions held for written response after the event.

Disclaimer: This Vendor Day is for planning and information-gathering purposes only and does not constitute a solicitation or commitment by the Government.

Consolidated Questions

Office of Commissioner April 2026

1) How does FDA define "real-time" and "near-real-time" in the context of post-market surveillance? What level of latency (seconds, minutes, hours, days) is considered acceptable or meaningful for operational use across different data types and signal categories?

2) How does FDA currently measure the time between when an event emerges and when it is detected in existing surveillance systems?

What would constitute success for this initiative—earlier detection, improved response time, increased signal coverage, or other metrics?

3) What data sources does FDA expect or prefer vendors to utilize? This includes FDA-managed data (AEMS, MAUDE, FAERS, inspection feeds), manufacturer-held data, publicly available external data (social media, literature, recalls), international regulatory data (EMA, PMDA, Health Canada, TGA), other government/state agency data, and real-world data that may not be VAERS/FAERS compliant. Will FDA provide access to its data sources via APIs or other mechanisms?

4) What is FDA's preferred model for data ownership, hosting, and infrastructure deployment—FDA-hosted, vendor-hosted, contractor-owned and operated (COOP), hybrid, or within specific environments like HALO? If contractor-hosted, what are the FedRAMP requirements and expected impact levels? Does FDA require Authority to Operate (ATO) at contract award or is a credible path to ATO acceptable?

5) Among the signal domains described (safety, product quality, supply chain, compliance/regulatory, public health) and product categories (drugs, biologics, devices, food, cosmetics, tobacco, veterinary), which are priorities for near-term operational capability versus exploratory efforts? What are each center's biggest challenges and priority needs for enhancement?

6) Is FDA interested in signal frameworks that explicitly link events across domains (e.g., quality issues leading to supply disruptions, or adverse events linked to manufacturing facility actions)? Should vendors demonstrate capability for cross-domain signal correlation (adverse event + facility inspection + recall)?

7) How does FDA define a "signal" in terms of validation, confidence, and actionability? What level of validation does FDA expect vendors to perform prior to signal delivery? How does FDA balance early awareness with the risk of increased noise/false positives, and does FDA seek vendors that provide validation, confidence scoring, false-positive reduction, and prioritization?

Consolidated Questions, cont’d…

Office of Commissioner April 2026

8) Does FDA prioritize signals corroborated across multiple independent sources? What are FDA's preferred criteria for prioritizing or ranking signals (severity, population impact, novelty, cross-source concordance), or should vendors propose their own frameworks?

9) What are FDA's preferences for signal delivery and technical integration? Does FDA prefer push-based/event-driven delivery versus pull-based/batch access? Is FDA seeking raw data, normalized event-level data, scored signals, narrative alerts, or a combination? Should signals be delivered via API, webhook, streaming interfaces, or through a vendor portal? Is FDA interested in a data/signals provider only, or would FDA consider a vendor-hosted end-to-end platform for signal detection, triage, visualization, and analyst workflow support?

10) Who are the intended end users of real-time compliance and surveillance data within and outside FDA (e.g., DEA, ATF, CBP, state enforcement)? Which FDA centers, offices, or programs will be primary users? What types of outputs, interfaces, or benchmark comparisons would be most useful for regulatory, surveillance, and compliance staff to act upon detected signals?

11) What are the contracting requirements and expectations? Please provide contact information for the Contracting Officer and Contracting Specialist. Is ATO required at contract award? Will FDA engage one or multiple contractors per signal type? Are specific qualifications required to submit a proposal (e.g., current/recent federal contracts)?

12) Will FDA develop signal detection algorithms and distribute them to contractors, or does FDA expect contractors to develop their own? Is FDA envisioning a pilot program first, and if so, what is the anticipated timeline? Will signal categories be implemented in phases or concurrently?

13) What types of proof cases, use-case demonstrations, or representative processing volumes would FDA find most helpful in evaluating analytical capabilities and scalability? Will evaluation criteria include source data breadth, existing analytics validation, production uptime, and demonstrated regulatory data capabilities? Will FDA give preference to commercially proven, cloud-native platforms over custom-developed solutions?

14) Will the Enhanced Real-Time Post-Market Surveillance program be architecturally integrated with or layered upon the existing Sentinel Initiative and ARIA system? What data interchange standards or APIs will govern that integration?

Q&A

Next Steps

Office of Commissioner

FDA will continue its market research activities related to real-time signal integration.

• RFI Responses Due: April 7, 2026, at 10:00 AM (ET)

• Submitted electronically to the Contracting Officer (CO) and Contracting Specialist (CS)

• Reference: RFI – Real-Time Post-Market Signal for Enhanced Surveillance

March 2026

Thank you!