FDA Launches AEMS Adverse Event Platform, With Device Database MAUDE to Follow in May

The US Food and Drug Administration has launched a single platform for viewing adverse event reports across the products it regulates, and says the device database MAUDE will be folded into it in May, according to an agency announcement dated March 11.

The new FDA Adverse Event Monitoring System, or AEMS, displays reports submitted for drugs, biologics, vaccines, cosmetics and animal food in one dashboard, the agency said. By the end of May 2026, the FDA said, AEMS will contain real-time adverse event reports for all FDA-regulated products, "consistent with meeting agency obligations not to release individually identifiable patient or consumer information."

Seven databases become one

The FDA said it previously processed about 6 million adverse event reports a year across a patchwork of seven databases that were expensive and had a poor user interface, making searches difficult. Those systems cost the agency about $37 million a year to operate, and the FDA said it expects to save about $120 million over the next five years, an agency estimate.

Legacy systems replaced by AEMS from launch include FAERS, which holds reports for drugs, biologics, cosmetics and color additives; VAERS, the vaccine reporting system the FDA co-manages with the Centers for Disease Control and Prevention, whose data the FDA will display in AEMS; and two AERS databases for animal drugs and animal foods.

Three more are scheduled to move in May, the agency said: MAUDE, the Manufacturer and User Facility Device Experience database that holds medical device reports; HFCS, for human foods and dietary supplements; and CTPAE, for electronic nicotine delivery systems and other tobacco products.

The FDA also said it will migrate historical adverse event data to AEMS, decommission certain legacy systems and roll out enhanced application programming interfaces and data analytics tools. Because AEMS will publish reports in real time rather than quarterly, the agency said it expects the system to significantly reduce Freedom of Information Act requests for unreleased reports.

What officials said

"The FDA's previous adverse event reporting systems were outdated and fragmented and made important data difficult to access," FDA Commissioner Marty Makary said in the announcement. "Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public."

Chief AI Officer Jeremy Walsh said consolidating the systems and converting to real-time publication "was challenging, but made possible by a highly aggressive schedule."

The agency acknowledged that adverse event reports "have limitations," while saying they can help identify potential safety signals, such as patterns or clusters of adverse events that might point to previously unknown risks.

Questions about verification

CIDRAP reported on March 12 that it was unclear how events would be assessed for credibility, or how and whether claims would be verified, in the context of real-time reporting. The University of Minnesota center also noted that the FDA "gave few other details" beyond its cost figures, and reported that the FDA said artificial intelligence will power the platform.

For medical devices, the switch comes in May, when MAUDE reports are scheduled to move into AEMS. The announcement did not say whether the existing MAUDE search page will stay online after the migration.