FDA Adverse Event Monitoring System (AEMS)

1 Expired ICR

Summary

The FDA Adverse Event Monitoring System (AEMS) consolidates multiple disparate reporting systems currently used across all FDA-regulated product categories, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary medicines. The unified platform is designed to enhance data quality and consistency through standardized reporting protocols, streamline reporting processes to reduce administrative burden on both internal FDA staff and external stakeholders, and strengthen safety surveillance capabilities through advanced case processing workflows, AI-based redaction and digitization tools, enhanced analytics, and comprehensive cross-product surveillance. Beyond adverse event reporting, AEMS serves as a centralized platform for managing consumer complaints, regulatory misconduct reports, and whistleblower submissions across all FDA centers.

Agency	HHS, FDA
Data Checkup

Historical Data Availability

No Known Issue

Future Data Availability

No Known Issue

Data Quality

No Known Issue

Statutory Context

No Known Issue

The FDA Adverse Event Monitoring System (AEMS) is the platform FDA uses to collect, manage, and analyze adverse event reports submitted under statutory and regulatory reporting requirements. Mandatory adverse event reporting applies to manufacturers and other responsible entities for many FDA-regulated products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations.

Staffing and Funding

Moderate Risk

From FY2024 to FY2026, the FDA lost close to 25% of its staff. The agency has also been impacted by leadership departures.

Policy

No Known Issue

Last updated: 2026-07-16

Details

Related ICRs
OMB Control Number	0910-0291
Authorizing Statutes	21 USC 301 et seq.

Reference Number	Title	Agency	Status	Request Type
202411-0910-004	FDA Adverse Event and Product Experience Reporting Systems (MEDWATCH and SPS electronic and paper-based collection)	HHS/FDA	Active	Revision of a currently approved collection
202603-0910-005	FDA Adverse Event and Product Experience Reporting Systems (MEDWATCH and SPS electronic and paper-based collection)	HHS/FDA	Active	No material or nonsubstantive change to a currently approved collection
202306-0910-006	Expired MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)	HHS/FDA	Active	No material or nonsubstantive change to a currently approved collection