Overview of Medical Device 

Reporting

Anike Freeman

Senior Consumer Safety Officer

Division of Industry and Consumer Education

Office of Communication and Education

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Value of Medical Device Reports

Consumers and Industry:

• Understand device safety and performance

• Design improvement

FDA:

• Monitor device safety and performance

• Assess need for regulatory action

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Learning Objectives

• Describe FDA’s regulatory authority for medical device 

reporting

• Define “MDR reportable event”

• Identify who reports to FDA and how

• Explain how FDA uses Medical Device Reports (MDRs)

• Demonstrate how to search for MDRs

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FDA’s Regulatory Authority

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Regulatory Authority

• Section 519 of the Food, Drug, and Cosmetic Act

– Pertains to records and reports on medical devices

– Grants FDA authority to require mandatory medical 

device reports from

• Manufacturers

• Importers

• Device User Facilities

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Medical Device Reporting Regulation

• Title 21 of Code of Federal Regulations (CFR), Part 803

• Establishes regulatory pathway for collecting 

reportable adverse event data

• Defines critical reporting roles, responsibilities, and 

deadlines

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“MDR Reportable Event”

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MDR Reportable Event

An MDR reportable event reasonably suggests a 

marketed device:

• May have caused or contributed to a death or 

serious injury, 

21 CFR 803.3(o)

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MDR Reportable Event

An MDR reportable event reasonably suggests a 

marketed device: 

• Malfunctioned, and

• Likely to cause or contribute to death or serious 

injury were it to recur

21 CFR 803.3(o)

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Who Reports MDRs and How

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Mandatory Reporters

Voluntary Reporters
Mandatory Reporters

• Manufacturers

• 21 CFR 803.3(l)

• Importers

• 21 CFR 803.3(j)

• Device User Facilities

• Example: Hospitals and Nursing Homes

• 21 CFR 803.3(d)

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How to Report: Mandatory Reporters 

Manufacturers and Importers:

• Electronic submission only

• Electronic Medical Device Reporting (eMDR) Final Rule effective

August 14, 2015

• Use Electronic Submissions Gateway (ESG)

– eMDR Guidance

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How to Report: Mandatory Reporters 

User Facilities: 

• Electronic submission encouraged

• eMDR Final Rule permits written reports

– Use Form 3500A

• Guidance: Medical Device Reporting For User Facilities

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Who Reports MDRs and How

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Voluntary Reporters
Voluntary Reporters

• Patients

• Health care Professionals

• Caregivers

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How to Report: Voluntary Reporters

• Online through MedWatch

• By postal mail

– Voluntary Reports – Form 3500

– Consumer-friendly version – Form 3500B

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How FDA Uses

Medical Device Reports

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Information Analysis

• CDRH values adverse event data collection and 

management 

• Maintains adverse event database and data files

• Provides eMDR support for mandatory 

reporters

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Medical Device Reports

• Over 800,000 reports received per year

• Reviewed by MDR analysts

– Medical and technical professionals

o Nurses

o Engineers

o Scientists

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MDRs Used to: Identify Trends

• Common or Novel 

• Frequency of reported event

• Severity of the event

• Associated risks

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Limitations of Data
MDRs Used to: Identify Possible Actions

• FDA inspection of manufacturer

• Changes to device labeling

• Notices to the public

– Example: Safety Communications

• Device recall

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Searching for

Medical Device Reports

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MAUDE

• Manufacturer and User Facility Device Experience 

(MAUDE) 

• Publicly searchable database of adverse event 

reports 

– User facility reports since 1991

– Voluntary reports since 1993

– Manufacturer reports since August 1996

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MAUDE

• Allows you to search using a variety of criteria

• Limit of 500 results per search

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MAUDE

• Important notes:

– Reports are redacted

– “Download Files” feature best for data more than 10 years old 

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Example Search

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Example Search

Product Code Classification Database 27
Example Search

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Example Search

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Example Search

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Example Search

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Summary

• MDRs are critical to public health

• Reports help generate postmarket data

• Information used to monitor medical device 

performance and safety

• Reported adverse event information is publicly available

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Contact Information

Interpretations of MDR policy: MDR Policy Group

• Phone: (301) 796-6670 (voice)

• Email: MDRPolicy@fda.hhs.gov

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Industry Education:

Three Resources for You

1. CDRH Learn: Multi-Media Industry Education

 Over 125 modules

 Videos, audio recordings, power point presentations, software-based “how to” modules

 Mobile-friendly: access CDRH Learn on your portable devices

www.fda.gov/CDRHLearn

2. Device Advice: Text-Based Education

 Comprehensive regulatory information on premarket and postmarket topics

www.fda.gov/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Contact DICE if you have a question

 Email: DICE@fda.hhs.gov

 Phone: 1(800) 638-2041 or (301) 796-7100 (Hours: 9 am-12:30 pm; 1 pm-4:30pm EST)

 Web: www.fda.gov/DICE

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Your Call to Action

• Understand your reporting responsibilities

• Notify FDA of reportable events

• Use the MAUDE database and educational resources

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