Medical Device Reporting for Mandatory Reporters

Slide 1

Hello, my name is Anike Freeman and I am a Senior Consumer Safety Officer within the Division of 

Industry and Consumer Education. In this module, I will inform you of Medical Device Reporting

requirements for mandatory reporters. Medical device reporting is a fundamental postmarket activity 

monitored by FDA.

Slide 2

Here are our learning objectives. First, we will explain and establish the regulatory basis for medical 

device reporting. Next, we will define key medical device reporting terms, identify mandatory reporters 

and go over their specific reporting responsibilities. Finally, we will determine how, when, and where

those reports are submitted and discuss the voluntary malfunction summary reporting program.

Slide 3

Let’s discuss FDA’s regulatory authority.

Slide 4

The regulatory authority for the Medical Device Reporting program comes from the United States Food, 

Drug, and Cosmetic Act. Section 519 pertains specifically to records and reports on medical devices. It 

grants FDA the authority to require medical device reports from manufacturers, importers, and device 

user facilities. The specifics of these requirements can be found in Title 21 of the Code of Federal 

regulations (or CFR), part 803.

Slide 5

21 CFR part 803 supplements the provision of the quality system regulation, 21 CFR 820, and contains 

detailed information on how to meet mandatory reporting requirements. It establishes the critical 

elements for a firm’s medical device reporting system which includes: a standardized complaint review 

process, timely and effective identification and communication of reportable events, and proper

documentation and recordkeeping.

Slide 6

As I mentioned earlier, Medical device reports, or MDRs, are also called out in the Quality System 

regulation. If you are a medical device manufacturer, you are likely already familiar with this regulation. 

21 CFR 820.198 specifically details the requirement for manufacturers to maintain a system for 

collecting and reviewing complaints about their devices. These are considered complaint files. These 

complaints must be assessed to determine whether they should be submitted to FDA as an MDR. This 

diagram illustrates an important point— all MDRs are considered complaints, but not every complaint 

must be reported to FDA through the MDR program.

Slide 7

Before we go further it is important to identify some of the key medical device reporting terms

Slide 8

The first term is “MDR reportable event”. The regulation states reportable events reasonably suggest a 

marketed device may have caused or contributed to a death or serious injury OR

Slide 9
that a marketed device malfunctioned and likely would have caused or contributed to death or serious 

injury if it recurred. This is important distinction. Sometimes, medical device users are fortunate, and no

harm is sustained during a device malfunction. However, that same malfunction could have triggered 

dramatically different results if, perhaps, the users were in a different position or less vigilant. These 

issues must be reported.

Slide 10

The next term is “malfunction”. A malfunction is the failure of a device to meet its performance 

specifications or otherwise perform as intended. These performance specifications DO include any and 

all claims made in the labeling for a device.

Slide 11

Finally, let’s define a serious injury. A serious injury means an injury or illness that: Is life-threatening, 

Results in permanent impairment of a body function or permanent damage to a body structure, OR

Necessitates medical or surgical intervention to preclude permanent impairment of a body function or 

permanent damage to a body structure. The term permanent means irreversible impairment or damage 

to a body structure or function, excluding trivial impairment or damage.

Slide 12

Now let’s identify our mandatory reporters and their responsibilities. 

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There are three categories of mandatory reporters. Manufacturers, importers, and device user facilities. 

You may read the complete descriptions for each of these reporting groups using the links provided on 

this slide.

Slide 14

Common responsibilities for all mandatory reporters include establishing and maintaining MDR 

procedures and event files, clearly identifying these files in their records, and permitting FDA employees 

to access, copy, and verify those records upon request. This most often happens during an FDA 

inspection.

Slide 15

Now we will define each type of reporter and their additional responsibilities. Let’s start with 

manufacturers. 

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A manufacturer is any person who manufactures, prepares, propagates, compounds, assembles, or 

processes a device

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This also includes those who repackage or initiate specifications for a device, or manufactures

components or accessories that are ready to be used and intended for commercial distribution

Slide 18

If you are a manufacturer, you are required to investigate each event to determine its cause. You must 

also obtain and submit any missing information from other reporters. When reporting, you should 

provide as much information as can be reasonably known about the event.
Slide 19

Reasonably known information includes information collected after contacting the person who reported 

the issue to you, information from your own internal testing and evaluation (if possible), and any 

information already in your possession (such as trends you’ve noticed with a specific device type).

Slide 20

The next category of mandatory reporters are importers.

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Importers are people who bring devices into the United States from a foreign country. They also further 

the marketing of that device from the place of original manufacture to the person who conducts final 

sale of the device to the ultimate user.

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Please note importers do not repackage devices. They do not change the container, wrapper, or label of 

the device in any way nor do they change the device package.

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Importers are not required to investigate reportable events. However, they must establish and maintain 

their own MDR procedures and event files. Their responsibilities do not extend further than those 

required of all mandatory reporters.

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The final category of mandatory reporters are user facilities. 

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A device user facility may be a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic 

facility, or outpatient treatment facility.

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They are NOT physician’s offices, school nurse offices, or employee health units.

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Device user facilities are responsible for submitting annual reports to FDA using Form 3419. If you are a 

user facility, please review this form and instructions for completing this annual report using the links

provided here.

Slide 28

Having established the roles and responsibilities of mandatory reporters, we can now discuss the 

logistics of how, when, and where MDRs are submitted to FDA.

Slide 29

Manufacturers and importers may only submit their reports electronically through the Electronic 

Submissions Gateway. This is the result of the electronic medical device reporting (eMDR) final rule 

which was issued in August of 2015. For more information on this requirement, you are welcome to 

refer to the eMDR guidance document.
Slide 30

User facilities, however, while encouraged to report electronically, are not required to do so. They still 

have the option to submit written reports to FDA by mail using Form 3500A. Please refer to the 

guidance document on medical device reporting for user facilities for more information.

Slide 31

FDA expects mandatory reporters to submit MDRs after becoming aware of reportable events and 

certain malfunctions. This reporting timeline varies and may be within 30 calendar days, 10 working 

days, or 5 working days. We will discuss this in more detail in just a few slides.

Slide 32

FDA considered firms to be aware whenever an employee becomes aware of the reportable event or a 

supervisory employee becomes aware the event requires remedial action.

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The term “remedial action” refers to any action, other than routine maintenance, that must be taken to 

prevent recurrence of a reportable event.

Slide 34

The table provided here serves as a consolidated overview of the information we have discussed this far. 

It explains who reports, what they are required to report, where they must submit those reports, and

when that information must be reported. Manufacturers must report deaths, serious injuries, and 

certain malfunctions to FDA within 30 calendar days of becoming aware. Certain events requiring 

remedial action, however, must be reported within 5 work days.

Slide 35

These are considered 5-day reports. They are submitted for events requiring remedial action to prevent 

an unreasonable risk of substantial harm to the public health. They must also be submitted whenever 

FDA has made a written request for a specific event involving a specific medical device to be reported 

within 5 work days.

Slide 36

Next we will summarize requirements for importers. Importers are required to report deaths and 

serious injuries to both FDA and the device manufacturer within 30 calendar days. However, they only 

need to report certain malfunctions to the manufacturer within 30 calendar days. Manufacturers can

then investigate these malfunctions to determine whether submission of an MDR would be appropriate.

Slide 37

Finally, device user facilities are only required to report deaths or serious injuries to FDA within 10 work 

days. A copy of these reports are sent by FDA to the manufacturer (when known) for their own 

evaluation.

Slide 38

Before we close, I’d like to share some information on the voluntary malfunction summary report 

program for device manufacturers.

Slide 39
This program came about because of a final rule FDA issued on August 17th, 2018. It specifically grants 

manufacturers the option to report certain malfunctions in summary format as opposed to individually. 

These reports would still be submitted electronically but on a quarterly basis. It would apply to 

malfunctions manufacturers become aware of after August 17th 2018. Please refer the federal register 

notice linked on this slide for detailed information on this rule.

Slide 40

There are conditions, however, for the voluntary malfunctions summary reporting program. 

Manufacturers may not use summary reporting if the reportable malfunction is associated with a 5-day 

report, is the subject of certain device recalls (such as a Class I recall), or if the device involved has been 

deemed ineligible by FDA. You can confirm a device’s eligibility by searching for it in the product 

classification dataset linked here. The description page for the device will include a line specifying its 

summary malfunction reporting status, as shown in this screenshot.

Slide 41

Summary reporting also cannot be used if FDA has determined individual reporting is necessary for that 

type of malfunction or that a certain manufacturer may not report in summary format. This would most 

commonly apply to manufacturers with significant regulatory compliance issues or failures. Finally, 

summary reporting may not be used for new types of reportable malfunctions for a device.

Slide 42

You may reference the table provided here to see the timeframe for each quarter of summary reporting 

and the deadline for submitting reports. The deadlines apply to malfunctions manufacturers became 

aware of within the corresponding reporting quarter. As you can see, that deadline is always a month 

after the end of a reporting quarter.

Slide 43

In summary, understand that MDRS are a regulatory requirement per 21 CFR 803. It is imperative that 

mandatory reporters understand and comply with their reporting requirements. We cannot emphasize 

enough how critical MDRs are to public health and safety.

Slide 44

If you have general MDR questions please contact the Division of Industry and Consumer Education. For 

assistance with more nuanced or complex questions involving the interpretation of MDR policies, please 

contact the MDR Policy Group using the contact information provided here. 

Slide 45

As always, we encourage you to refer to CDRH Learn and Device Advice for additional regulatory 

education. You may also contact DICE directly with any general regulatory questions you may have. We 

are happy to assist you by phone or email. Please refer to the information provided on this slide for our 

hours of operation.

Slide 46

Remember, it is your responsibility to stay current on MDR policies and regulations. This responsibility 

includes establishing your firm’s MDR procedures and being proactive about meeting your reporting 

deadlines. We hope you’ve found this presentation helpful and informative. Thank you for watching.

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