The FDA has announced that MAUDE device data will become available in its Adverse Event Monitoring System, or AEMS. DeviceWatch is ready to support teams through that transition, with FDA channel monitoring already in place. Today, our public device search continues to use openFDA, whose device adverse event documentation still identifies MAUDE as its source.
An announced change to the FDA’s platform does not by itself establish that the data source behind an existing search has changed.
What FDA announced
FDA launched AEMS on March 11, 2026. Its announcement described a unified platform for adverse event reports and named MAUDE among the legacy systems it planned to replace in May. It also described plans to migrate historical data and introduce enhanced APIs.
That May target was a plan. The launch announcement does not establish that a device migration subsequently completed, that MAUDE retired or that a particular device API became available.
The MDR Data Files page, marked current as of September 2, 2026, says MAUDE data will become available in AEMS during 2026. It continues to provide MAUDE downloads. These pages establish the intended direction, but do not confirm a completed MAUDE retirement.
What a MAUDE search uses today
The openFDA device adverse event documentation still names MAUDE as its source and describes a weekly update cadence. That is the documented source DeviceWatch uses for device adverse event searches.
AEMS is the platform name, MAUDE is the device dataset named in those documents and openFDA is the API through which DeviceWatch queries it. A change to one does not establish a change to all three.
The documented update cadence also does not guarantee that every recent report is already available. FDA publishing delays and the time between an event and its report can affect what a search returns.
How DeviceWatch is preparing to support AEMS
DeviceWatch’s FDA channel monitoring checks openFDA, MAUDE bulk files, the MDR Data Files page and the AEMS page. Relevant changes to the AEMS page are flagged for review, rather than treated as proof that a new device feed is ready.
The ingestion layer separates source-specific record handling from the rest of the product. That gives us a place to adapt device data access as FDA documents the transition. Our commitment is to support AEMS as its device channels become available and can be validated.
Preparation is not a completed integration. Before changing the source used by DeviceWatch, we would need to verify the supported access method, record identifiers, field mappings and historical coverage. Any limits on continuity would need to be visible. We are not promising an automatic switch or a cutover without gaps.
Until that work is done, DeviceWatch keeps using the documented openFDA device channel, and the source name shown to users should describe the data being read at that point in time.
What the platform change does not resolve
A new platform does not remove the limits of adverse event reporting. FDA warns that these reports can be incomplete, inaccurate or unverified. Report counts alone do not establish a device’s failure rate or prove that it caused an injury.
Those limits matter in MAUDE searches today and will still matter when interpreting reports through another platform. Source changes also need to be considered when comparing counts across time.
The DeviceWatch public data index offers device-category and manufacturer views of the current public data. Its monitor signup is there for teams that want to follow the devices they watch.