By: Caitlin A. Koppenhaver, Attorney with Florida Healthcare Law Firm and Chief Industry Advisor to APA
FDA’s announcement regarding the launch of AEMS is worth watching. The Adverse Event Monitoring System is intended to consolidate multiple reporting systems across FDA-regulated product categories into a single platform, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary products.
Legacy systems to be replaced by AEMS now include:
FAERS (FDA Adverse Event Reporting System) — containing reports for drugs, biologics, cosmetic products, and color additives.
VAERS (Vaccine Adverse Event Reporting System) — containing reports for vaccines. Note: The FDA will display VAERS data in AEMS. VAERS is co-managed by the FDA and Centers for Disease Control and Prevention.
AERS (Adverse Event Reporting System) — two databases containing reports for animal drugs and animal foods.
Legacy systems to be replaced by AEMS in May 2026 include:
MAUDE (Manufacturer and User Facility Device Experience) — containing reports for medical devices.
HFCS (Human Foods Complaint System) — containing reports for human foods and dietary supplements.
CTPAE (Center for Tobacco Products Adverse Event Reporting System) — containing reports for Electronic Nicotine Delivery Systems (ENDS) and other tobacco products.
More than a technology update, AEMS reflects an effort to improve data quality and consistency, streamline reporting, reduce administrative burden, and strengthen FDA’s ability to monitor trends across product categories through enhanced analytics and more integrated review tools.
FDA also indicated that the platform will support not only adverse event reporting, but also consumer complaints, regulatory misconduct reports, and whistleblower submissions. The broader takeaway is that postmarket oversight depends heavily on infrastructure, and systems like this can directly affect how efficiently concerns are identified, evaluated, and addressed.