FDA Medical Device Reporting

Know when and how to file an MDR

U.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. 

Global Medical Device Reporting