Who is required to submit Medical Device Reports to FDA?

Under 21 CFR Part 803, mandatory reporters include device manufacturers (domestic and foreign), importers, and device user facilities (hospitals, nursing homes, ambulatory surgical facilities). Manufacturers and importers must report deaths, serious injuries, and certain malfunctions. User facilities must report deaths to FDA and the manufacturer, and serious injuries to the manufacturer. Voluntary reporting by healthcare professionals and consumers is encouraged but not required.

What are the reporting timelines for MDR submissions?

Manufacturers and importers must submit 30-day reports for events involving death, serious injury, or reportable malfunctions. A 5-day emergency report is required when the manufacturer becomes aware of an MDR-reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to public health, or when FDA requests a 5-day report. Assurentry tracks all deadlines from the date the firm becomes aware of the event.

What is the difference between a death, serious injury, and malfunction report?

A death report is required when a device may have caused or contributed to a patient death. A serious injury report is required when a device caused or contributed to a serious injury (life-threatening, resulting in permanent impairment, or requiring medical/surgical intervention). A malfunction report is required when the device malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Each category uses MedWatch Form 3500A but with different coding and narrative requirements.

What are the penalties for failing to submit required MDR reports?

Failure to submit required MDR reports can result in FDA warning letters, consent decrees, civil monetary penalties, product seizure, injunctions, and criminal prosecution under 18 U.S.C. 1001 for false statements. FDA has issued warning letters and consent decrees to companies with systemic MDR non-compliance. Late reporting can also trigger increased scrutiny during FDA inspections and may affect 510(k) or PMA review outcomes.

What is eMDR and how does it differ from paper submission?

eMDR (electronic Medical Device Reporting) is FDA's mandatory electronic submission system for Medical Device Reports. Since August 2015, FDA requires that all mandatory MDR reports be submitted electronically through the eMDR gateway using the FDA-approved XML format. Paper submission of MedWatch 3500A forms is no longer accepted for mandatory reporters except in cases of hardship exemption. Assurentry handles all eMDR electronic formatting and gateway submission requirements.

What are the MDR obligations for foreign device manufacturers?

Foreign manufacturers who market devices in the U.S. have the same MDR obligations as domestic manufacturers under 21 CFR Part 803. They must monitor complaints, evaluate events for reportability, and submit eMDR reports within required timelines. Foreign manufacturers must also designate a U.S. Agent who can assist with FDA communications, though the MDR reporting obligation remains with the manufacturer. Assurentry provides both eMDR support and U.S. Agent services for foreign device firms.

What role does the U.S. Agent play in Medical Device Reporting?

The U.S. Agent serves as the communication link between FDA and the foreign manufacturer but does not assume the manufacturer's MDR reporting obligations. However, FDA may contact the U.S. Agent regarding MDR-related inquiries, inspection scheduling, or follow-up requests. Having a knowledgeable U.S. Agent who understands MDR requirements can help foreign manufacturers respond to FDA inquiries quickly. Assurentry's combined eMDR and U.S. Agent service provides seamless compliance coverage.

How does Assurentry help with eMDR compliance?

Assurentry provides comprehensive eMDR support: we help establish complaint-handling procedures that feed into MDR evaluation, perform reportability determinations, prepare complete MedWatch 3500A reports with accurate event narratives, submit through the eMDR electronic gateway, manage 30-day and 5-day timelines, coordinate annual malfunction summaries, and maintain inspection-ready records. Our per-report pricing of $299 covers the full submission lifecycle from event evaluation through FDA acknowledgment.

eMDR Reporting • Official FDA Process

Electronic Medical Device Reporting
(eMDR)

Mandatory adverse event reporting for medical device manufacturers and importers through FDA's electronic Medical Device Reporting (eMDR) system under 21 CFR Part 803.

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Event Triage

We evaluate the adverse event to determine reportability under 21 CFR Part 803: death, serious injury, or malfunction requiring a report to FDA.

Report Preparation

We prepare the MedWatch Form 3500A with complete event narrative, device identification, patient outcome data, and manufacturer assessment.

eMDR Submission

We submit the report electronically through FDA's eMDR system within the required timeline (30 days for death/serious injury, 5 days for emergencies).

Follow-Up & Tracking

We track FDA acknowledgment, manage supplemental reports if new information emerges, and maintain records for inspection readiness.

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Reportability determination and event triage
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Annual malfunction summary coordination
Ongoing adverse event monitoring support

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