No. As of June 2026, the FDA's MAUDE database is not gone, not deprecated and not replaced. Device adverse event data still flows through MAUDE and the openFDA device/event API, exactly as it did last year. The legacy MAUDE search interface is still online.
If you have read otherwise — and several vendor blogs are claiming MAUDE was decommissioned in May 2026 — you have read something the FDA never said. We verified every claim in this article against FDA primary sources on June 9, 2026. The links are included so you can check our work.
What AEMS Actually Is Today
The FDA launched the Adverse Event Monitoring System (AEMS) on March 11, 2026 (fda.gov/safety/fda-adverse-event-monitoring-system-aems). It is a real system and a real migration. But so far it covers drugs, not devices.
The initial AEMS release consists of two things: drug adverse event data migrated from FAERS, the FDA Adverse Event Reporting System, and a public dashboard built on Qlik Sense for exploring that data.
That is the whole launch. No device data. No public API. No developer documentation, no API keys, no endpoints.
AEMS traces back to the FDA's August 2025 announcement of its push toward real-time adverse event data. The ambition is genuine: one modern system for adverse events across drugs, biologics and devices, replacing infrastructure that dates to the 1990s. Device data is part of the plan. It is not part of the present.
What the Vendor Claims Get Wrong
Two claims are circulating in vendor marketing and blog posts. Both fail verification.
Claim 1: "MAUDE was decommissioned in May 2026." It was not. The legacy MAUDE search interface remains online at accessdata.fda.gov (accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm). You can run a search right now. The FDA has published no decommission date, no sunset notice and no migration completion announcement for device data.
Claim 2: "AEMS API keys are available." There is no public AEMS API. The only public-facing AEMS surface is the Qlik Sense dashboard, which covers drug data. If a vendor tells you they are pulling device data from an AEMS API, ask them for the endpoint URL. There isn't one to give.
Whether these claims come from misreading FDA announcements or from the urge to manufacture urgency, the pattern is familiar: a real change is coming, so unverified specifics fill the vacuum. The fix is the same as always. Go to the primary source.
What FDA's Own Pages Say
Three FDA pages settle the question.
The MDR Data Files page, current as of April 30, 2026, says this: "In 2026, the data in the MAUDE Database will become available in the FDA's Adverse Event Monitoring System (AEMS)." Note the tense. Will become. No month, no cutover plan, no decommission date (fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files).
The openFDA device/event documentation (open.fda.gov/apis/device/event/) shows the device adverse event API alive and current. The openFDA updates page (open.fda.gov/about/updates/) shows the device event dataset last refreshed on June 2, 2026 — one week before this article was published — with roughly 25 million records. There is no deprecation notice anywhere in the documentation.
The AEMS page itself describes the drug data migration and the public dashboard. It does not announce device data availability, an API, or a MAUDE retirement date.
Put together: the FDA says device data moves to AEMS at some point in 2026, and until then MAUDE is the system of record, served weekly through openFDA.
How to Verify This Yourself
Don't take our word for it either. Three checks, five minutes:
- Open the MAUDE search interface at accessdata.fda.gov and run any query. If it loads, MAUDE is not decommissioned.
- Open open.fda.gov/about/updates/ and find the device event row. The last-updated date tells you whether data is still flowing.
- Search the openFDA device/event documentation for a deprecation notice. You will not find one.
Any vendor claim that survives those three checks is worth engaging with. Most don't.
For belt and suspenders, archive what you find. A dated PDF of each page in your quality records turns a five-minute check into evidence you can hand an auditor a year from now.
Why the Confusion Exists
The misinformation has a traceable anatomy.
AEMS genuinely launched in March. "FDA launches AEMS" is a true headline, and it is one careless paraphrase away from "FDA has replaced its adverse event databases." The drug-only scope gets lost in the retelling.
The FDA's own forward-looking language does some of the work too. "In 2026, the data in the MAUDE Database will become available in AEMS" is a sentence about the future. Quoted without the tense, it reads like an announcement of something that already happened.
And there is a commercial incentive. A deadline sells software. "MAUDE is gone, migrate now" converts better than "the FDA will move device data at some unspecified point this year." That does not make every vendor repeating the claim cynical — some are just repeating each other — but it explains why the false version spreads faster than the verified one.
What Device Companies Should Do Now
The right response to the AEMS transition is preparation, not panic.
Keep your surveillance running against openFDA. It is the current, FDA-supported source for device adverse event data. Switching away from a live, weekly-refreshed source toward a system that does not yet serve device data would be the actual compliance risk.
Don't rewrite your SOPs to reference AEMS yet. Your post-market surveillance plan should describe the data source you actually use. Naming a system that does not serve device data invites exactly the audit finding you are trying to avoid. Our companion piece on preparing your PMS program for AEMS covers SOP wording that survives the transition without a second rewrite.
Monitor the three FDA pages above on a recurring schedule. When the FDA announces the device cutover, those pages will move first. A monthly check, logged in your quality system, is cheap insurance.
Archive your raw API responses. If the data model changes during the migration, an archive of what openFDA returned — and when — protects the reproducibility of every surveillance decision you made against the old source.
Treat vendor timelines as unverified until the FDA publishes them. Including ours. The standard is simple: if a date does not appear on an FDA page, it is a guess.
What Not to Do
A few moves look proactive but create real problems:
- Do not replace "MAUDE" with "AEMS" across your quality documentation. Your documented process must match your actual process, and your actual process queries MAUDE data.
- Do not pause surveillance "until the migration settles." Your reporting obligations under 21 CFR Part 803 and your PMS obligations under EU MDR continue regardless of which FDA system hosts the data.
- Do not buy tooling on the strength of claimed AEMS integration. There is nothing for device data to integrate with yet.
The Bottom Line
MAUDE is going away eventually. The FDA has said so, in writing, with a 2026 horizon. But "sometime this year" and "already happened in May" are very different claims, and only one of them is true.
If leadership asks, the one-sentence summary is: the FDA has announced a destination for device adverse event data but not a departure time, and until it does, MAUDE via openFDA remains the correct and compliant source.
DeviceWatch monitors device adverse events through the openFDA API, because that is where the FDA serves the data today. When the FDA moves device data into AEMS, we will follow the migration server-side. Our customers will not change anything: same products, same review queue, same reports, new plumbing underneath.
That is what the transition should look like for you too — an infrastructure event, not a compliance crisis. The companies that get burned will be the ones that acted on dates the FDA never published.