RFI - Enhanced Surveillance 3.16.2026.pdf

1 | P a g e

Real-Time Post-Market Signal For Enhanced Surveillance

MARKET RESEARCH PURPOSES ONLY – NOT A REQUEST FOR PROPOSAL OR SOLICITATION

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.

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.

Information obtained through this Request for Information (RFI) will assist the Government in determining the availability of industry capabilities, potential technical integration approaches, and possible cost models associated with providing real-time signal feeds to FDA systems.

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 solicitation in the future.

Background The FDA conducts post-market surveillance activities to monitor the safety, quality, and performance of regulated products throughout their lifecycle.

Existing surveillance systems include initiatives such as:

• Sentinel Initiative, Biologics Effectiveness and Safety (BEST) Initiative, National Evaluation System for health Technology (NEST) active surveillance using distributed queries across healthcare data partners

• Adverse Event Reporting Systems (AEMS) industry and Self Reporting adverse events case processing and monitoring

• Medwatch Online, safety information and adverse event reporting programs

• Safety Reporting Portal (SRP), small business and volunteer enabled interface to report safety reports to FDA

• Manual monitoring, review of literature, manufacturer reports, and other sources

These programs support the analysis of healthcare data and adverse event reports to detect potential safety or quality concerns affecting FDA-regulated products.

While these systems provide important analytical capabilities, FDA is interested in exploring whether real-time signals generated by industry or other external sources could complement existing surveillance activities by providing earlier awareness of emerging events affecting regulated products.

Examples of potential signals may include:

• Safety events or adverse reactions

• Product recalls or quality issues

• Manufacturing disruptions

• Supply chain shortages

2 | P a g e

• Public health alerts

• Compliance or regulatory actions

FDA is particularly interested in understanding whether such signals could be delivered to FDA systems through Application Programming Interfaces (APIs) or other automated integration mechanisms that enable timely transmission of information.

Signals of interest may apply across FDA-regulated products, including drugs, biologics, medical devices, combination products, vaccines, tissues, tobacco products, food and cosmetics, veterinary products, and other regulated commodities. Signal types span multiple domains critical to post-market surveillance and regulatory oversight across the entire FDA mission.

General Instructions Responses to this Request for Information (RFI) should not exceed 15 pages in length, including any appendices.

A complete response should address the questions below to the extent relevant. Responses should describe the respondent’s capabilities, experience, and technical approach in sufficient detail to support FDA’s market research objectives.

Merely stating that an organization can perform the work without supporting information, may limit the Government’s ability to assess the respondent’s capabilities.

This RFI is issued for market research purposes only. Responses will be used to inform FDA’s understanding of the marketplace and potential approaches for integrating real-time signals into FDA surveillance systems

Requested Information Interested organizations are requested to provide information addressing the following areas.

1. Organizational Overview

Provide a brief corporate profile including:

• Organization name and location

• Organization website

• Years in business

• Types of services provided

• Types of clients served (Federal, commercial, healthcare, etc.)

• Organization size and workforce

• Point of contact information

• Unique Entity Identifier (UEI)

• DUNS number and CAGE code (if applicable)

• SBA size designation and socioeconomic status (e.g., Small Business, WOSB, EDWOSB, HUBZone, SDVOSB, 8(a), etc.)

• Number of employees

• Most recent annual receipts amount as defined by SBA

3 | P a g e

2. Signal Types and Data Sources

Describe the types of signals your organization can provide, including:

• Types of events or signals generated

• Data sources used to generate signals

• Coverage characteristics (geographic, population, product types)

• Timeliness and update frequency of signals

3. Signal Detection and Validation

Describe methods used to detect and generate signals, including:

• Analytical methods or algorithms used

• Signal validation approaches

• Methods used to reduce false positives

• Approaches for prioritizing or ranking signals

4. Technical Integration Approaches

Describe technical approaches your organization could use to deliver signals to external systems, including:

• API architecture (REST APIs, streaming APIs, webhooks, etc.)

• Data formats and interoperability standards

• Authentication and security mechanisms

• Push vs. pull integration models

• Expected update frequency and latency

5. Security and Privacy

Describe how your organization addresses security and privacy considerations, including:

• Data protection practices

• Compliance with relevant security standards (HIPAA, NIST, FISMA, etc.)

• Data governance approaches

6. Rough Order of Magnitude (ROM) Cost Information

If available, respondents may provide high-level information regarding potential pricing approaches, such as:

• Subscription or licensing models

• Transaction-based pricing models

• Volume-based pricing tiers

• Implementation or integration costs

Cost information provided will be used for market research purposes only.

4 | P a g e

7. Relevant Experience

Provide examples of similar capabilities or implementations your organization has provided for:

• Federal agencies

• Healthcare organizations

• Public health surveillance initiatives

• Safety monitoring systems

Examples should focus on similar capabilities rather than contract performance evaluations.

Signal Types of Interest FDA is interested in signals that may provide early awareness of events affecting FDA-regulated products.

Examples may include:

Safety Signals

• Adverse event reports

• Safety alerts or emerging safety concerns

• Changes to product labeling or safety communications

Product Quality Signals

• Product recalls

• Manufacturing deviations or quality issues

• Contamination or counterfeit product detection

Supply Chain Signals

• Product shortages

• Manufacturing disruptions

• Distribution or supply chain integrity issues

Compliance and Regulatory Signals

• Warning letters

• Inspection findings

• Import alerts or regulatory enforcement actions

Public Health Signals

• Disease outbreaks or environmental health events

• Signals related to product use patterns or population health trends

FDA also welcomes information regarding innovative signal types, including signals derived from digital sources, advanced analytics, or machine learning methods.

Notice of Intent Responses to this RFI will assist the Government in understanding the availability of industry capabilities related to real-time signal generation and delivery. Information received may inform future activities, 5 | P a g e including additional market research, industry engagement sessions or technical discussions, pilot initiatives, and potential future acquisition strategies. Participation in this RFI does not guarantee participation in any future procurement.

Disclaimer This notice does not obligate the Government to award a contract or otherwise pay for information provided in response.

The Government reserves the right to use information provided by respondents for market research and acquisition planning purposes.

Respondents are advised that the Government is under no obligation to acknowledge receipt of responses or provide feedback regarding submitted information.

Vendor Day Registration FDA plans to host a Vendor Day to provide additional context regarding this market research effort and allow industry participants an opportunity to ask questions.

Date: April 1 Time: 12:00 PM – 2:00 PM (Eastern Time) Location: Virtual (meeting information will be provided upon registration)

Additional logistical details will be provided to registered participants.

Organizations interested in participating in the Vendor Day should submit a registration request including the following information. Participation is limited to two (2) registrants per organization.

• Organization name

• Attendee name(s)

• Attendee title(s)

• Email address

• Organization website

Registration requests should be submitted via email to: ODTVendorExcellence@fda.hhs.gov

Vendor Day Registration Deadline: March 26, 2026, at 10:00AM

RFI Response Instructions

• Responses to this RFI should be submitted electronically by April 7, 2026, at 10:00AM to the

Contracting Officer (CO) and Contracting Specialist (CS).

• Responses should reference: “RFI – Real-Time Post-Market Signal for Enhanced Surveillance” mailto:odtvendorexcellence@fda.hhs.gov