The FDA has not moved MAUDE to AEMS. DeviceWatch spent about two months saying it had. That is corrected across every customer-facing surface as of this week, and this post is the correction.
In late June we renamed the FDA’s device adverse event database everywhere in the product: landing page, help center, dashboard, onboarding, transactional emails, exported PDF reports. The copy read “AEMS (formerly MAUDE)” on first mention and AEMS after. A changelog entry stated the migration completed in May 2026. Three blog articles were written on that premise, one of them answering “is MAUDE going away” with “it already has”.
None of that was true.
What the FDA’s page says
We went back to the primary source on 26 August. The FDA’s AEMS page says the agency “is implementing” AEMS. Present tense, not past. The page is filed under Drugs. Its subtitle reads “[Formerly FDA Adverse Event Reporting System (FAERS)]” and every resource it links is a FAERS resource.
So AEMS is real, and right now it is FAERS’s successor. FAERS is the drug side. Devices appear as future scope with no migrated data, no device API and no announced date.
MAUDE is the live source of record for device adverse events. It is what openFDA serves and what DeviceWatch reads.
How we got it wrong
AEMS exists, the FDA is implementing it and devices are genuinely named in its scope. Read quickly, that looks like a migration in progress. Read carefully, it says the drug database was renamed and the device one was not.
We read quickly. The rename then propagated through the product in a single pass, which is how one misreading became every surface at once.
A company selling regulatory data got a regulatory fact wrong, and the failure was not checking the claim against the page that would have refuted it in a minute.
What changed
Every customer-facing surface names MAUDE again. Landing page, SEO metadata and social cards, terms, privacy, trust, changelog, Trend Watch, dashboard screens, onboarding, emails and the exported PSUR, CAPA and event reports.
The help center glossary makes MAUDE the primary entry again and documents AEMS accurately: announced for devices, pending. The FAQ answer to “was MAUDE retired” is now “not yet”.
The three blog articles are rewritten against the FDA’s primary sources, each carrying a visible correction note rather than a quiet edit. The “is MAUDE going away” answer is “not yet”. The post-cutover checklist is reframed as a readiness checklist. The migration guide is forward-looking again.
The public changelog’s “AEMS Transition” entry is replaced with “FDA Channel Monitoring”, which describes what actually shipped: an automated watch on openFDA, the MAUDE bulk files and the FDA’s own AEMS pages. When the device migration is announced, we will hear it from the FDA rather than from an inference about the FDA.
If you build on this data
MAUDE is still where device adverse event reports live, and openFDA is still how you query them. AEMS will matter for devices eventually. It does not yet, there is no published date, and anyone telling you the cutover happened in May is repeating something we helped put into circulation.