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U.S. Department of Health and Human Services

Medical Devices

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Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

Mandatory Medical Device Reporting:

The Medical Device Reporting (MDR) regulation (21 CFR 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 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 For more information please see the draft guidance for manufacturers on medical device reporting.

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
 

REPORTERWHAT TO REPORTREPORT FORM #TO WHOMWHEN
Manufacturers30 day reports of deaths, serious injuries and malfunctionsForm FDA 3500AFDAWithin 30 calendar days of becoming aware of an event
 5-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 healthForm FDA 3500AFDAWithin 5 work days of becoming aware of an event
ImportersReports of deaths and serious injuriesForm FDA 3500AFDA and the manufacturerWithin 30 calendar days of becoming aware of an event
 Reports of malfunctionsForm FDA 3500AManufacturerWithin 30 calendar days of becoming aware of an event

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

Please 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
 

REPORTERWHAT TO REPORTREPORT FORM #TO WHOMWHEN
User FacilityDevice-related DeathForm FDA 3500AFDA & ManufacturerWithin 10 work days of becoming aware
User FacilityDevice-related Serious injuryForm FDA 3500AManufacturer. FDA only if manufacturer unknownWithin 10 work days of becoming aware
User FacilityAnnual summary of death & serious injury reportsForm FDA 3419FDAJanuary 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.


For Questions about Medical Device Reporting, including interpretation of MDR policy:

Food and Drug Administration
Center for Devices and Radiological Health
MDR Policy Branch
10903 New Hampshire Avenue
WO Bldg. 66, Room 3217
Silver Spring, MD 20993-0002

 

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