FDA Adverse Event Monitoring System (AEMS): What Replaced MAUDE for Medical Devices

FDA replaces MAUDE with AEMS — unified adverse event dashboard, migration timeline, data limitations, and reporting changes for device manufacturers.

What Is the FDA Adverse Event Monitoring System (AEMS)?

The FDA Adverse Event Monitoring System (AEMS) is the FDA's new unified platform for adverse event data across all FDA-regulated product categories. Launched on March 11, 2026, AEMS replaces six previously fragmented databases — including the Manufacturer and User Facility Device Experience (MAUDE) database used for medical device adverse event reports — with a single, centralized system.

For medical device manufacturers, importers, and user facilities, AEMS is now the primary public-facing system for accessing device adverse event data. Historical MAUDE data has been migrated into AEMS, and new Medical Device Reports (MDRs) are processed in real time through the unified platform.

Direct link to the AEMS Public Dashboard: fis.fda.gov

The FDA's Chief AI Officer described AEMS as "the biggest technical transformation in agency history." The previous fragmented systems cost approximately $37 million per year to operate and processed over 6 million adverse event reports annually across seven separate databases. The FDA projects that AEMS will save approximately $120 million over five years through consolidation and modernization. The platform is designed to:

Consolidate adverse event data from drugs, biologics, vaccines, medical devices, cosmetics, food, tobacco, and veterinary products into a single system
Enhance data quality through standardized reporting protocols and AI-based redaction and digitization tools
Streamline reporting processes to reduce administrative burden on both FDA staff and external stakeholders
Strengthen safety surveillance through advanced case processing workflows, enhanced analytics, and cross-product surveillance capabilities

What AEMS Replaces

AEMS consolidates six legacy adverse event reporting systems that previously operated independently across different FDA centers:

Legacy System	Product Category	AEMS Migration Status
FAERS (FDA Adverse Event Reporting System)	Drugs, biologics, cosmetics, color additives	Migrated March 2026
VAERS (Vaccine Adverse Event Reporting System)	Vaccines (co-managed with CDC)	Migrated March 2026
AERS (Adverse Event Reporting System)	Animal drugs and animal foods	Migrated March 2026
MAUDE (Manufacturer and User Facility Device Experience)	Medical devices	Migrated by end of May 2026
HFCS (Human Foods Complaint System)	Human foods, dietary supplements	Migrated by end of May 2026
CTPAE (Center for Tobacco Products Adverse Event Reporting System)	Tobacco products, ENDS	Migrated by end of May 2026

For the medical device industry, the most significant change is the retirement of MAUDE. MAUDE had been the primary public database for device adverse events since the 1990s, housing over 16 million reports. All historical MAUDE data has been migrated into AEMS, and new MDRs are now processed through AEMS in real time.

The VAERS website, its reporting infrastructure, and reporting requirements for vaccines have not changed with the AEMS migration. The CDC continues to co-manage VAERS alongside FDA.

AEMS Timeline for Medical Device Manufacturers

Date	Milestone
March 11, 2026	FDA launches AEMS with drug, biologic, vaccine, cosmetics, and animal product data
March 11, 2026	AEMS Public Dashboard goes live with initial product categories
By end of May 2026	MAUDE data migrated to AEMS; new device MDRs processed in real time
By end of May 2026	HFCS and CTPAE data migrated
October 1, 2026	Postmarketing ICSRs for human drug products, biological products, and drug- or biologic-led combination products must use ICH E2B(R3) data standards (replacing E2B(R2)) when submitted via ESG NextGen
Ongoing	FDA plans to roll out enhanced APIs and data analytics tools

The October 2026 ICH E2B(R3) transition is separate from the AEMS launch and applies specifically to postmarketing ICSRs for human drug products, biological products, and drug- or biologic-led combination products submitted via the Electronic Submissions Gateway Next Generation (ESG NextGen). After September 30, 2026, FDA will no longer accept postmarketing ICSRs using ICH E2B(R2) data standards for these product categories. This transition does not directly change how device MDRs are submitted — device MDR submission channels remain the same as of June 2026.

How AEMS Differs from MAUDE

For regulatory professionals accustomed to MAUDE, AEMS represents a fundamentally different interface and data access model.

Data Access and Search

Feature	MAUDE	AEMS
Interface	Form-based query with separate pages for event/date/product criteria	Interactive dashboard with tabs for each product category
Search	Text-based field queries on the accessdata.fda.gov platform	Dashboard-based search with filtering, visualization, and export
Data refresh	Periodic updates (monthly or quarterly batches)	Daily refresh (near real-time)
Scope	Medical device reports only	Cross-product: drugs, devices, vaccines, cosmetics, food, tobacco
Data range	Reports from 1991 onward (over 16 million device reports)	Reports from 1968 to present (all migrated legacy data)
Export	CSV/TXT downloads	Line listing downloads from dashboard
Disclaimer	Static text on the MAUDE about page	Mandatory disclaimer pop-up before dashboard access

Key Functional Differences

Unified product view. AEMS allows queries across all FDA-regulated product categories in one system. For combination products (drug-device or biologic-device), this means adverse event data for both the device and the drug/biologic component can be queried from the same platform.
Near real-time data. Unlike MAUDE, which updated on a periodic basis, AEMS data is refreshed daily. New MDRs are processed and made available to the public through the dashboard within approximately 24 hours.
Mandatory disclaimers. Before accessing the AEMS dashboard, users must acknowledge a detailed disclaimer explaining data limitations. The FDA has built these caveats directly into the user flow — a response to widespread public misinterpretation of legacy adverse event data, particularly VAERS data during the COVID-19 pandemic.
AI-powered tools. FDA has integrated AI-based redaction and digitization tools into AEMS case processing workflows. The agency has described these as part of its modernization efforts, though specific details on the AI models used have not been publicly documented.

Using the AEMS Public Dashboard for Medical Device Searches

The AEMS Public Dashboard at fis.fda.gov is a web-based tool that does not require registration or login. Here is how to use it for medical device adverse event queries.

Step 1: Access and Disclaimer

Navigate to the AEMS Public Dashboard. Before accessing any data, you must acknowledge a mandatory disclaimer that states, among other things:

"Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event"
AEMS data alone cannot establish event rates, evaluate changes in event rates over time, or compare event rates between products
Reports may contain incomplete, inaccurate, or unverified information

Step 2: Navigate to Device Data

Once the disclaimer is acknowledged, the dashboard presents tabs for different product categories. When medical device data was migrated from MAUDE, a dedicated device tab became available alongside the existing drugs/biologics, cosmetics, and vaccines tabs.

Step 3: Search and Filter

The dashboard supports queries by:

Device product code or classification name
Manufacturer or brand name
Date range (event date, report date, or date received by FDA)
Event type (death, serious injury, malfunction)
Report source (manufacturer, user facility, importer, voluntary)
Model number and catalog number
Patient outcomes

Unlike MAUDE's form-based text queries, the AEMS dashboard provides interactive filtering that updates results in real time as you adjust parameters.

Step 4: Export Data

Search results can be exported as line listings for offline analysis. This is similar to MAUDE's download functionality but integrated directly into the dashboard interface.

What Has Not Changed: Reporting Requirements

AEMS is a data management and public access platform. It does not change the underlying legal reporting requirements for medical device adverse events.

Mandatory Reporting Obligations (21 CFR Part 803)

The same three categories of reporters remain legally obligated to submit MDRs:

Reporter Type	What Must Be Reported	Timeline
Manufacturers	Deaths, serious injuries, and malfunctions that could cause or contribute to death/serious injury	30 days (5 days if remedial action is required)
Importers	Deaths and serious injuries	30 days
Device User Facilities	Deaths and serious injuries	10 working days for deaths; semi-annual for serious injuries

Voluntary Reporting

Healthcare professionals, patients, consumers, and caregivers continue to submit voluntary reports through the MedWatch program (FDA Form 3500). These reports are processed into AEMS alongside mandatory reports.

Submission Channels

As of June 2026, the FDA has not announced changes to the submission channels for device MDRs. Manufacturers continue to submit reports through established electronic submission pathways. The key upcoming change is the October 2026 transition from ICH E2B(R2) to E2B(R3) data standards for ICSRs submitted through the Electronic Submissions Gateway Next Generation (ESG NextGen) portal.

Cross-Product Visibility and Real-Time Data Implications

One of AEMS's most significant changes is the ability to view adverse events across all FDA-regulated product categories in a single dashboard. For combination products — drug-device or biologic-device products — this means adverse events involving both the device and the drug/biologic component can now be queried from the same system, rather than requiring separate searches in MAUDE and FAERS.

The near real-time data refresh also has important implications:

More accessible data cuts both ways. While faster access to adverse event information benefits manufacturers conducting signal detection, the same data is also accessible to plaintiff attorneys, competitors, researchers, and journalists. Companies should monitor AEMS proactively rather than being surprised by events discovered by external parties.
FOIA reduction. The FDA has stated that real-time public access to AEMS data is expected to reduce Freedom of Information Act (FOIA) requests, as data that previously required FOIA requests is now directly searchable.
Signal monitoring frequency. With daily data refreshes, manufacturers may want to increase monitoring frequency from the traditional quarterly schedule to weekly or even daily for high-risk devices.
Raw data interpretation risks. Experts have cautioned that releasing unvetted raw data in near real-time carries risks. Peter Pitts, former FDA associate commissioner and president of the Center for Medicine in the Public Interest, warned that "adverse event reporting should not be a crowdsourcing proposition" — emphasizing that raw AEMS data has not been verified or assessed for causation by FDA staff. This is an important caveat for any company using AEMS data for decision-making.

Practical note: As of mid-2026, the AEMS FAQ still occasionally refers to the system as "FAERS" in some places — a holdover from the system's original name. This is expected to be updated as the system matures.

AEMS Data Limitations for Medical Device Analysis

The FDA is explicit about the limitations of AEMS data. These limitations are substantially the same as those that applied to MAUDE, but the FDA has made them more prominent in the AEMS interface.

Causation Is Not Established

A report in AEMS does not mean the device caused the adverse event. Reports reflect the observations or opinions of the reporting party, which may include manufacturers, healthcare providers, or consumers. The FDA has not independently verified the causal relationship between the device and the reported event in most cases.

Reporting Rates ≠ Incidence Rates

AEMS cannot be used to calculate the incidence or prevalence of an adverse event because:

Under-reporting is significant. Studies have estimated that the FDA receives reports for only a fraction of actual adverse events, particularly those occurring in outpatient settings where physicians are not mandatory reporters.
Reporting volume is influenced by many factors beyond actual event frequency, including media attention, FDA safety communications, litigation activity, and manufacturer reporting practices.
Denominator data is not available. AEMS does not contain device usage data (number of devices in use, patient exposure time, procedure volumes), making rate calculations impossible from AEMS data alone.

Data Quality Issues

Duplicate reports exist in the system. Multiple reports may describe the same event from different sources (manufacturer, user facility, importer).
Incomplete information is common. Reports may lack critical details such as device model numbers, lot numbers, patient demographics, or clinical outcomes.
Coding inconsistencies occur across reports and over time as coding practices evolve.

Comparing Products Is Not Valid

The FDA explicitly states that AEMS data alone "cannot be used to compare event rates between products." Differences in reporting volume between two devices may reflect differences in market share, reporting practices, device age, patient populations, or other confounding factors — not differences in actual safety profiles.

Practical Applications for Medical Device Companies

Despite its limitations, AEMS remains one of the most important publicly available resources for medical device post-market surveillance. Here is how companies use it effectively.

Signal Detection and Vigilance

Monitor AEMS for adverse event reports involving your own devices and competitors' devices. Set up regular search routines — weekly or monthly — using product codes, brand names, and model numbers. Look for:

Sudden spikes in report volume
New or unexpected event types
Recurring device problem codes
Clusters associated with specific lot numbers or manufacturing dates

Predicate Device Research for 510(k) Submissions

Before submitting a 510(k), review AEMS data for your intended predicate device. This helps you:

Identify known failure modes to address in your risk analysis (ISO 14971)
Understand the types of adverse events FDA reviewers are aware of
Design verification and validation tests that address real-world failure modes
Prepare for potential FDA questions about predicate device safety

EU MDR Clinical Evaluation and PMCF

For manufacturers with CE-marked devices, AEMS is a recognized source of external post-market data. EU Notified Bodies expect manufacturers to search publicly available adverse event databases as part of:

Clinical Evaluation Reports (CERs) under MDR Article 61 and Annex XIV
Post-Market Clinical Follow-up (PMCF) plans under MDR Annex XIV, Part B
Periodic Safety Update Reports (PSURs) under MDR Article 86

Due Diligence and Transaction Support

Investors, acquirers, and legal teams use AEMS data during due diligence to assess:

The safety profile of a target company's device portfolio
Whether the company has been responsive to known adverse events
Trends in reporting volume that may signal emerging issues
Comparison of the company's reporting practices against industry norms

Complaint Handling and CAPA

AEMS data can supplement your internal complaint data by revealing events reported to the FDA that were not reported directly to your company. This is particularly relevant for:

Events reported by user facilities or importers directly to the FDA
Voluntary reports from healthcare professionals or patients
Events that occurred at facilities that are not your direct customers

Transition Checklist for Medical Device Manufacturers

If your team is transitioning from MAUDE-based workflows to AEMS, here are the key steps.

Immediate Actions

Bookmark the AEMS dashboard at fis.fda.gov and update all internal documentation and SOPs that reference MAUDE URLs
Train your team on the new dashboard interface. The AEMS dashboard is "radically different in appearance and search functionality" from MAUDE, according to Emergo by UL analysts who have evaluated the platform
Update signal detection SOPs to reflect the new search interface and near real-time data availability. You may be able to increase monitoring frequency from monthly to weekly given the daily data refresh

Short-Term Actions (Q3–Q4 2026)

Prepare for ICH E2B(R3) transition (if applicable). Starting October 1, 2026, postmarketing ICSRs for human drug products, biological products, and drug- or biologic-led combination products must use E2B(R3) data standards when submitted via ESG NextGen. If your company submits these types of ICSRs, review your electronic submission systems and processes to confirm compatibility with the new format. Device-only MDR submission channels are unaffected
Validate search strategies. Run parallel searches in both MAUDE (while still accessible) and AEMS to confirm your standard query parameters produce equivalent results in the new system
Update vendor agreements. If you outsource vigilance or signal detection to a CRO or consulting firm, confirm they have transitioned to AEMS-based workflows

Ongoing Monitoring

Monitor FDA communications for updates on AEMS feature releases, API availability, and data analytics tools the agency has said it will roll out
Review new disclaimer language periodically. The FDA may update AEMS data limitation statements as the system evolves
Track the ESG NextGen portal for changes to electronic submission requirements that may affect how device MDRs are submitted to AEMS

AEMS and the Broader FDA Modernization Landscape

AEMS does not exist in isolation. It is part of a broader FDA modernization effort that includes several concurrent changes affecting the medical device industry:

Quality Management System Regulation (QMSR) — Effective February 2, 2026, the QMSR replaced the Quality System Regulation (21 CFR 820) and aligned FDA requirements with ISO 13485:2016. QMSR impacts how device manufacturers manage complaint handling, CAPA, and post-market surveillance processes that feed into AEMS reporting.
EUDAMED mandatory registration — From May 28, 2026, EU device registration data must be entered into EUDAMED. Companies selling in both the US and EU now need to monitor adverse event data in both AEMS and EUDAMED.
FDA inspection process changes — The FDA stopped using QSIT (Quality System Inspection Technique) on February 2, 2026, and now follows the updated Compliance Program 7382.850. Inspectors are trained to mine post-market data more aggressively, including AEMS data, to identify patient safety signals before and during inspections.

Frequently Asked Questions

Is MAUDE still accessible?

As of June 2026, MAUDE data has been migrated into AEMS. The MAUDE search page at accessdata.fda.gov may remain temporarily available during the transition, but all new device MDRs are processed through AEMS. Companies should transition their workflows to the AEMS dashboard.

Do my MDR reporting requirements change with AEMS?

No. Your legal obligations under 21 CFR Part 803 remain the same. You must still report deaths, serious injuries, and reportable malfunctions within the same timelines. The change is in how the FDA stores and makes that data publicly available, not in what you must report.

How do I submit MDRs to AEMS?

Manufacturer MDR submission channels have not changed as of June 2026. Continue using your established electronic submission pathways. The upcoming change is the October 2026 transition from ICH E2B(R2) to E2B(R3) data standards for ICSRs submitted through the ESG NextGen portal.

Can I still download AEMS data in bulk?

The AEMS Public Dashboard supports line listing downloads from search results. The FDA has indicated it will roll out enhanced APIs and data analytics tools for more sophisticated querying as the system matures. Check fda.gov/safety/fda-adverse-event-monitoring-system-aems for updates on API availability.

How should I cite AEMS data in clinical evaluation reports?

Reference the AEMS Public Dashboard as the data source, include your search parameters (product code, date range, event types), the date of your search, and the number of reports identified. Acknowledge the data limitations described by the FDA (reporting bias, under-reporting, lack of denominator data, no causal inference). This approach is consistent with MDCG guidance on literature search protocols for clinical evaluation.

What if I find adverse events in AEMS that were not reported to my company?

This is common. User facilities and importers may report events directly to the FDA without notifying the manufacturer. If you identify events in AEMS for your device that your complaint handling system does not already capture, you should evaluate those events through your complaint handling and CAPA processes per 21 CFR Part 803 and, as of February 2026, the QMSR requirements aligned with ISO 13485:2016.