FDA Adverse Event Monitoring System (AEMS)
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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 |
|---|
Details
| OMB Control Number | 0910-0291 | |||
|---|---|---|---|---|
| Authorizing Statutes | 21 USC 301 et seq. | |||
| Related ICRs |
| 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 | New 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 |