FDA Medical Device Reporting
Know when and how to file an MDRU.S. FDA Medical Device Reporting
What is 21 CFR Part 803 (Medical Device Reporting)?
This regulation establishes mandatory postmarket surveillance requirements to ensure that the FDA is informed of deaths, serious injuries, and device malfunctions that could potentially cause harm if they were to recur. It applies to manufacturers, importers, and user facilities (e.g., hospitals)
Manufacturer Responsibilities Under 21 CFR 803
Determine if the event is reportable
You must submit an MDR to FDA if:
- The device may have caused or contributed to a death or serious injury, or
- The device malfunctioned, and the malfunction would likely cause or contribute to a death or serious injury if it were to recur
“Serious injury” includes life-threatening events, permanent impairment, or medical/surgical intervention to prevent these outcomes.
- FDA requests it specifically
- The issue requires remedial action to prevent an unreasonable risk of substantial harm to public health
Reporting timelines
| Type of Event | Reporting Deadline |
| Death | 30 calendar days from becoming aware (and immediately notify FDA and, if applicable, the user facility) |
| Serious injury | 30 calendar days |
| Malfunction (potential to cause serious injury/death) | 30 calendar days |
| 5-Day MDR (Special Cases) | Within 5 working days if: |
How to submit MDRs
Use the FDA’s Electronic Submissions Gateway (ESG) to file:
- Form FDA 3500A (mandatory version for manufacturers)
- Submit electronically using the Electronic Medical Device Reporting (eMDR) format, typically via HL7 ICSR XML
You must also maintain internal procedures for MDR (per 21 CFR 803.17) and ensure adequate training.
Maintain, review and investigate records
MDR submittors are required to:
- Investigate each reportable event
- Keep complete records of the investigation and root cause
- Retain all MDR files for at least 2 years or longer if required by another regulation
- Make records available to FDA investigators upon request
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Follow-up and corrections
If new and relevant information becomes available:
- Submit a follow-up MDR using the same Event ID and clearly marking it as a follow-up report
- Include updated findings, risk assessment, or corrective actions taken
Additional Quality System Notes for MDR Compliance
Establish MDR procedures in accordance with 21 CFR 803.17
Your documented procedures must cover:
- How you determine event reportability
- Investigation processes
- Submission timelines
- Recordkeeping
- Training and internal audits of the MDR process
Integration With Other Regulations
Events triggering an MDR may also:
- Require recall reporting under 21 CFR 806
- Lead to a CAPA under 21 CFR 820.100
- Be part of a field safety corrective action for EU reporting
Summary Table: Manufacturer MDR Duties
|
Responsibility |
Regulation/Action |
| Identify death/serious injury/malfunction | 21 CFR 803.50 |
| Submit report (Form 3500A) | eMDR via FDA ESG within 30 days (or 5 days if urgent) |
| Maintain records | 21 CFR 803.18 (at least 2 years) |
| Investigate and document events | 21 CFR 803.17 |
| Submit follow-up reports | If new info arises post-initial report |
| Train personnel & audit procedures | As part of Quality System Regulation (QSR/QMSR) |
International
Manufacturers who sell devices internationally must also be aware of global device reporting requirements. Read more.