What adverse event reporting is
Adverse event reporting is how FDA learns about harm, malfunctions and other safety problems with products already on the market. Manufacturers, importers and certain user facilities are required to report; healthcare professionals and patients may report voluntarily. The reports feed FDA’s safety signal detection, which can lead to labeling changes, safety communications or recalls.
The scale is large. FDA receives “over two million medical device reports” each year (FDA), and its adverse event systems together “processed approximately 6 million adverse event reports per year” (FDA).
Who reports what, and how
| Reporter | Form | Status |
|---|---|---|
| Health professionals, consumers, patients | MedWatch Form 3500: “For use by health professionals, consumers, and patients” (FDA) | Voluntary |
| Consumers | Form 3500B: “A consumer-friendly version of the 3500 reporting form” | Voluntary |
| Device manufacturers, importers, user facilities | Form 3500A or electronic equivalent (FDA) | Mandatory under 21 CFR 803 |
| Drug application holders | Electronic individual case safety reports | Mandatory under 21 CFR 314.80 |
Medical device reporting (21 CFR 803)
| Report | Deadline | Trigger |
|---|---|---|
| 30-day report | ”no later than 30 calendar days after the day that you receive or otherwise become aware of information” | Device may have caused or contributed to a death or serious injury, or malfunctioned in a way that would likely do so if it recurred |
| 5-day report | ”no later than 5 work days after the day that you become aware of” | Events requiring remedial action to prevent unreasonable risk of substantial harm, or when FDA requests |
| Supplemental report | As new information becomes available | Follow-up to an initial report |
Source: eCFR, 21 CFR 803. Manufacturers and importers “must submit initial and supplemental or followup reports to FDA in an electronic format” (eMDR).
The clock starts at awareness, which is why complaint handling matters. Under the QMSR, complaint records must address MDR reportability, including “For complaints that must be reported to FDA under part 803” (21 CFR 820.35). FDA has cited late filing “beyond the 30‐calendar day timeframe” in a 2026 warning letter (FDA, Zoll).
Drug adverse experience reporting (21 CFR 314.80)
Applicants must submit 15-day Alert reports for adverse experiences that are “serious and unexpected” “as soon as possible but no later than 15 calendar days from initial receipt of the information by the applicant” (eCFR, 21 CFR 314.80). Reports must be in an “electronic format that FDA can process, review, and archive.” Periodic reports cover other events.
What changed in 2025 and 2026
- Daily FAERS publication. In August 2025, FDA “began daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS).” Commissioner Makary said, “Adverse event reporting should be fast, seamless and transparent” (FDA).
- AEMS consolidation. In March 2026, FDA launched the Adverse Event Monitoring System, a “new unified platform for analyzing adverse event reports” that replaces a “patchwork of seven databases” (FDA). AEMS aims “to consolidate multiple disparate reporting systems currently used across all FDA-regulated product categories” (FDA), and RAPS reported it will also replace the MAUDE device database (RAPS).
- AI at FDA. FDA’s Elsa tool “can summarize adverse events to support safety profile assessments” (FDA). Faster review means reporting gaps are more visible.
Public databases have limits. FDA warns that MDR data “is not intended to be used either to evaluate rates of adverse events” (FDA, MAUDE).
Building a reliable reporting process
- Capture every potential event from complaints, service, literature, social media and sales, with the awareness date recorded.
- Screen quickly using documented reportability criteria and decision trees.
- Escalate potential reports to trained reviewers with time remaining on the clock.
- Investigate in parallel; do not wait for root cause before reporting on time.
- Submit electronically and track acknowledgments.
- File supplemental reports as information arrives.
- Trend events and feed signals into CAPA and risk management.
- Audit timeliness and decisions not to report.
Adverse event reporting checklist
- Procedures cover 21 CFR 803 or 314.80, as applicable
- Awareness date captured consistently across all intake channels
- Reportability criteria documented with examples
- Decisions not to report justified and reviewed
- eMDR or electronic ICSR submission working and monitored
- 30-day, 5-day and 15-day timelines tracked with alerts
- Supplemental reporting process defined
- Events trended and linked to CAPA and risk files
- Staff trained, including sales and service
- AEMS changes monitored
Check reportability decisions with evidence
Missed or late reports often trace back to complaint records that never asked the right question. AskDona reviews complaint files and reportability assessments against 21 CFR 803, 314.80 or your own procedure, flags missing decisions or unsupported conclusions, and cites the passage behind every finding. Qualified reviewers make every reporting decision.
Run a sample reportability assessment on a batch of complaint records. AskDona shows the evidence; your safety team decides.
FAQ
What is adverse event reporting? Reporting of harm, malfunctions and safety problems with marketed products to FDA, mandatory for manufacturers and voluntary for health professionals and patients.
What is the deadline for a device MDR? 30 calendar days from awareness for most reports, and 5 work days for certain events (eCFR).
What is a 15-day Alert report? A drug safety report for serious and unexpected adverse experiences, due within 15 calendar days (eCFR).
What is MedWatch? FDA’s safety information and adverse event reporting program, including Forms 3500, 3500A and 3500B.
What is AEMS? FDA’s new unified Adverse Event Monitoring System, launched in March 2026.
References
All pages opened and checked by October 13, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| FDA: MDR data files | Regulator | Sep 2, 2026 | Report volume |
| FDA: AEMS launch | Regulator | Mar 11, 2026 | AEMS |
| FDA: AEMS page | Regulator | Mar 11, 2026 | AEMS scope |
| RAPS: AEMS | Professional body | Mar 11, 2026 | MAUDE replacement |
| FDA: Reporting serious problems | Regulator | Sep 26, 2025 | MedWatch forms |
| FDA: Mandatory reporting requirements | Regulator | Mar 27, 2025 | Form 3500A |
| eCFR: 21 CFR 803 | Regulation | Current | Device timelines |
| eCFR: 21 CFR 820.35 | Regulation | Current | Complaint-MDR link |
| FDA warning letter: Zoll | Regulator | Apr 30, 2026 | Late MDR |
| eCFR: 21 CFR 314.80 | Regulation | Current | Drug 15-day reports |
| FDA: Daily FAERS publication | Regulator | Aug 22, 2025 | FAERS change |
| FDA: Elsa launch | Regulator | Jun 2, 2025 | AI review |
| FDA: About MAUDE | Regulator | Dec 8, 2025 | Data limits |