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 In this section:

        Postmarket Requirements (Devices)

Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

                        
                About Manufacturer and User Facility Device Experience (MAUDE)
          Medical Device Reporting Regulation History


                eMDR – Electronic Medical Device Reporting
          MDR Adverse Event Codes Home
          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
          Postmarket Requirements (Devices)
          Mandatory Reporting Requirements: Manufacturers, Importers and Device User FacilitiesPostmarket Requirements (Devices) Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities
  	
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Mandatory Medical Device Reporting
	Summary of Mandatory Reporting Requirements for Manufacturers and Importers
	Summary of Mandatory Reporting Requirements for User Facilities
	Complaint Files and Medical Device Reporting
	Electronic Medical Device Reporting (eMDR)
	Questions about Medical Device ReportingMandatory Medical Device Reporting:

The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. The regulation specified that reports be filed on the FDA's Medwatch Form 3500A or an electronic equivalent. The FDA published a final rule****on Feb. 14, 2014, requiring manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. This rule will be effective as of Aug.14, 2015.

Information on the requirements for each mandatory reporting group follows:

**Manufacturers:** Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. (Key terms are defined in 21 CFR 803.3.) Instructions are available for completing the required 3500A form. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. For more information please see the guidance for manufacturers on medical device reporting.

**Voluntary Malfunction Summary Reporting Program**: As of August 2018, certain manufacturers may be eligible to volunteer to submit summary reports of medical device adverse events on a quarterly basis to the FDA. Learn about if you are eligible in the Federal Register Notice.**Importers:** Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Summary of Mandatory Reporting Requirements for Manufacturers and Importers

REPORTER
			WHAT TO REPORT
			REPORT FORM #
			TO WHOM
			WHEN**Manufacturers**
			30 day reports of deaths, serious injuries and malfunctions
			Form FDA 3500A *
			FDA
			Within 30 calendar days of becoming aware of an event5-day reports for an event designated by FDA or an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health
			Form FDA 3500A *
			FDA
			Within 5 work days of becoming aware of an event**Importers**
			Reports of deaths and serious injuries
			Form FDA 3500A *
			FDA and the manufacturer
			Within 30 calendar days of becoming aware of an eventReports of malfunctions
			Form FDA 3500A *
			Manufacturer
			Within 30 calendar days of becoming aware of an event

* Or electronic equivalent

**Device User Facility Reporting Requirements**

A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.

User facilities must also submit annual reports to the FDA by January 1 of each year as described in 803.33.

Form 3419 Annual User Facility Report

Medical Device Reporting Annual User Facility Report - Form FDA3419
	Instructions for Completing the Medical Device Reporting Annual User Facility Report, Form FDA3419Please note that 803.30 (which addresses User Facility Reporting Requirements) does NOT state that device user facilities are required to report device malfunctions where the malfunction would likely cause or contribute to death or serious injury if the malfunction were to recur.

Although a user facility is not required to report a device malfunction, they can voluntarily inform the FDA of such product problems through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA.

The FDA’s "Medical Device Reporting for User Facilities" guidance document provides additional information.

Summary of Mandatory Reporting Requirements for User Facilities

REPORTER
			WHAT TO REPORT
			REPORT FORM #
			TO WHOM
			WHENUser Facility
			Device-related Death
			Form FDA 3500A
			FDA & Manufacturer
			Within 10 work days of becoming awareUser Facility
			Device-related Serious injury
			Form FDA 3500A
			Manufacturer. FDA only if manufacturer unknown
			Within 10 work days of becoming awareUser Facility
			Annual summary of death & serious injury reports
			Form FDA 3419
			FDA
			January 1 for the preceding year



Complaint Files and Medical Device Reporting

Complaint files are linked to MDR event files because a complaint must be evaluated to determine if it is a reportable adverse event. A complaint is any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. Manufacturers and importers are required to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints. Importers are also subject to complaint files because "initial distributors of foreign entities" fall under the definition of a manufacturer in 21 CFR 820.3.

Complaint files that are found to be reportable MDR events should be maintained in a separate portion of the complaint file or otherwise clearly identified.

Electronic Medical Device Reporting (eMDR)

More information on how to submit MDRs electronically is available on the eMDR website.

Guidance for Industry, User Facilities and FDA Staff: eMDR - Electronic Medical Device Reporting
	Final Rule on Electronic Medical Device Reporting (eMDR)For Questions about Medical Device Reporting, including interpretation of MDR policy:

Call: (301) 796-6670
	Email: MDRPolicy@fda.hhs.gov
	Or write to:Food and Drug Administration
Center for Devices and Radiological Health
MDR Reporting Team
10903 New Hampshire Avenue
WO Bldg. 66, Room 3217
Silver Spring, MD 20993-0002

Other Resources

General Medical Device Reporting Information
	Manufacturer and User Facility Device Experience (MAUDE) Database
	MDR Database Search: This database captures MDRs that were received prior to July 31, 1996.
	Variance from Manufacturer Report Number Format [MDR letter]
	Variance from Manufacturer Report Number Format - No. 5
	Submitting Freedom of Information Act (FOIA) Requests
	CDRH Learn with Medical Device Reporting
	Medical Device Reporting and Lasik
	Medical Device Reporting and Needlesticks (PDF - 34KB)

                                                                                  Content current as of:
      05/22/2020
                  
                   
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsTopic(s)
			  PostmarketMandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities                
                          

                        About Manufacturer and User Facility Device Experience (MAUDE)
          Medical Device Reporting Regulation History


                        eMDR – Electronic Medical Device Reporting
          MDR Adverse Event Codes
 
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