Overview of Medical Device Reporting

Slide 1

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

and Consumer Education. In this module, I will provide an overview of Medical Device Reporting, a key 

postmarket activity monitored by FDA.

Slide 2

Before we begin, it is important to highlight the value of medical device reports. Information on medical 

device adverse events benefit everyone. Consumers can be empowered to make educated decisions 

about their healthcare and Industry may use this information to improve the design and safety of their 

products over time. As a regulatory agency, FDA is particularly interested in understanding how medical 

devices perform once they enter the market. This allows the agency to monitor device safety and 

determine when regulatory intervention may be necessary to mitigate serious concerns.

Slide 3

Our learning objectives for today are as follows. First, we will establish FDA’s regulatory authority for 

medical device reporting. We will then define an MDR reportable event and identify who reports to FDA 

and how those reports are submitted. Afterwards, we will explain how FDA uses medical device reports 

and demonstrate how you can independently search for MDRs.

Slide 4

Let’s establish FDA’s regulatory authority over medical device reporting

Slide 5

FDA’s regulatory authority stems 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. We will discuss these 

groups later on in the presentation.

Slide 6

The medical device reporting regulation is found in Title 21 of the Code of Federal regulations (or CFR), 

part 803. It establishes how adverse events involving medical devices can be reported to FDA. It also 

defines important reporting roles, responsibilities, and deadlines.

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So what is an MDR Reportable Event?

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The regulation states MDR reportable events reasonably suggest a marketed device may have caused or 

contributed to a death or serious injury OR 

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That a marketed device malfunctioned and the malfunction likely would have caused or contributed to 

death or serious injury if it recurred. This is an important distinction that helps FDA hone in on events 

that are especially serious or harmful to the public.

Slide 10
Now we will talk about who reports this information. There are two categories. mandatory and 

voluntary reporters. First, we will discuss mandatory reporters.

Slide 11

Mandatory reporters are medical device manufacturers, importers, and device user facilities. Examples 

of user facilities are hospitals and nursing homes. You may refer to the regulations linked here for a

complete description of each of these roles. 

Slide 12

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

Submissions Gateway. This is the result of the electronic medical device reporting (or 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 13

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.

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Next we will discuss voluntary reporters.

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Voluntary reporters are, essentially, everyone else. They do not have a regulatory obligation to submit 

MDRs but their input will always be welcomed and encouraged by FDA. Most voluntary reporters are 

patients, healthcare professionals (such as doctors and nurses), and consumers who may be serving as 

caretakers.

Slide 16

Voluntary reporters may report adverse events online through the MedWatch portal linked here. They 

may also download the report form from the FDA website and submit it by postal mail. All voluntary 

reporters may use Form 3500, however, Form 3500B serves as a more consumer-friendly option.

Slide 17

Now that we’ve established who reports and how that information is delivered to FDA, let’s talk about 

how FDA uses medical device reports.

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Proper information analysis is really the key to effectively understanding reported information and its 

potential implications. CDRH values adverse event data collection and management and is responsible 

for maintaining the database that houses this information. The Center also provides eMDR technical 

support. This is to ensure timely communication of these events to FDA by mandatory reporters.

Slide 19

On average, FDA receives over 800,000 adverse event reports each year. These reports are read and 

reviewed by FDA analysts who have years of professional and technical experience. Many of these 

individuals have backgrounds in nursing, medicine, engineering, and science and may specialize in 

certain device product areas, such as dental or orthopedic devices.
Slide 20

When reviewing reports, analysts seek to identify trends. They determine which types of device 

problems are common and make note of unique or novel events. They also monitor the frequency and 

severity of a product problem as they may indicate an emerging safety issue in need of correction. 

Combined, all this information contributes to FDA’s assessment of potential risks to public health.

Slide 21

MDRs are also used to identify possible actions to be taken. If an analyst determines a trend is 

particularly concerning, they may escalate the issue to Center management. This may then prompt FDA 

to take regulatory action in response to these reports and trends such as-- inspecting the manufacturer, 

recommending changes to device labeling, issuing public health notices, or possibly recalling the device.

The information you provide FDA helps make this possible.

Slide 22

Previously, I mentioned that CDRH maintains a database of this reported information. Let’s discuss this 

tool and how you can search for medical device reports.

Slide 23

MAUDE stands for manufacturer and user facility device experience. It is a publicly searchable database 

containing medical device adverse event reports from as far back as the early 90s. Both industry and 

consumers may refer to this database when seeking information on specific medical devices.

Slide 24

Here, you will find a screenshot of the database. You will notice it allows you to search by a variety of 

terms such as product problem, brand name, or manufacturer. Of course, you do not need to enter 

information in all of fields to complete a search. Simply enter your known search terms to obtain results.

This search engine caps the number of results per search to 500, so bear this in mind if you are in need 

of large sets of data.

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Another point to remember is that reports are redacted to protect patients and any other confidential 

information. When reading a report, you may notice certain words are missing. This redaction is part of 

the MDR review process before anything is uploaded into the database. Additionally, reports more than 

10 years old are best accessed by using the “download files” feature. Clicking this link takes you to a 

supplemental webpage which contains a series of downloadable zip files. These files contain adverse 

event reports for each reporting year as far back as 1995.

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Having a general understanding of the database and its features, let’s do an example search.

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Here, I have decided to search for event types documented as malfunctions. I’ve narrowed the search 

further by setting the dates to go from March 1st of 2015 to the end February, 2019. If I do not change 

these dates, the database defaults to providing results from the previous month. I have also identified

product code DZE, which is for dental implants. Product codes may be found by searching the product 

classification database. If you do not know the product code for a device, you may use a different search 

criterion such as the brand name or model number.
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When I click search, I receive a series of results spanning multiple pages.

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You will notice my search terms yielded over 500 reports. The database is letting me know the results 

displayed are incomplete and that I may need to narrow my search further. If I absolutely must collect

all of this information, I can utilize the download files function instead, as I mentioned earlier.

Slide 30

You will also notice report results will be listed by date, with the most recently received reports 

appearing first, followed by older records.

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When I click one of the results, it takes me to a page which provides more detail. Here, I can see the 

model number and review the specific device problem and event description. Remember, reports 

contain as much information as is reasonably available to the individual filing the report. This means 

certain details, such as model numbers, may not always be available. However, careful compilation and 

review of multiple reports on a specific device type may help you better understand common issues 

people experience with that product.

Slide 32

In summary, medical device reports are critical to public health and safety. The information provided by

mandatory and voluntary reporters generates robust medical device performance data. FDA uses all

data to monitor device performance and safety and inform its regulatory decision-making. This 

information is not only available to the Agency, but also the public through the MAUDE database. You, 

too, may use these reports to make informed decisions.

Slide 33

We hope you found this information useful. The following slides contain links to additional, relevant 

resources. For assistance with more nuanced or complex questions involving the interpretation of MDR 

policies, please contact the MDR Policy Group.

Slide 34

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

also encourage you to refer to CDRH Learn and Device Advice which contain additional educational 

materials for your benefit. We hope you continue to educate yourself on these important regulatory 

activities.

Slide 35

In closing, here is your call to action. Take time to properly understand your reporting responsibilities. 

Notify FDA of reportable events when you become aware of them. And finally, try using the MAUDE 

database and other educational resources FDA has provided. I hope you have found this presentation to 

be helpful. Thank you for watching.

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