Medical Device Reporting for 

Mandatory Reporters

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
Learning Objectives

• Describe FDA’s regulatory authority for medical device 

reporting

• Define medical device reporting terms

• Identify mandatory reporters and their responsibilities

• Determine how, when, and where to report

• Explain the Voluntary Malfunction Summary Reporting 

Program

2
FDA’s Regulatory Authority

3
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, and 

device user facilities

– Reporting requirements found in 21 CFR 803

4
Medical Device Reporting: 21 CFR 803

• In addition to provisions of the Quality System Regulation

– 21 CFR 820

• Establishes requirements for firm’s medical device reporting 

system

– Standardized complaint review process

– Timely, effective identification and communication of reportable events

– Documentation and recordkeeping

21 CFR 803.17

5
Medical Device Reports (MDRs) and

Complaint Files

21 CFR 803

Medical Device 

Reporting

21 CFR 820.198

Complaint Files

6
Medical Device Reporting Terms

7
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)

8
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)

9
Malfunction

The failure of a device to meet its performance 

specifications or otherwise perform as intended.

• Performance specifications include all claims made 

in labeling for the device

(21 CFR 803.3(k))

10
Serious Injury

Refers to an injury or illness that:

• Is life-threatening

• Results in permanent impairment of a body function

• Results in permanent damage to a body structure

• Necessitates medical or surgical intervention

(21 CFR 803.3(w))

11
Mandatory Reporters and

Their Responsibilities

12
Mandatory Reporters

• Manufacturers

• 21 CFR 803.3(l)

• Importers

• 21 CFR 803.3(j)

• Device User Facilities

• 21 CFR 803.3(d)

13
Common Responsibilities

• Establish and maintain MDR procedures

– (21 CFR 803.17)

• Establish and maintain MDR event files

– (21 CFR 803.18)

• Clearly identify MDR event files in their records

– (21 CFR 803.18)

• Permit FDA employees to access, copy, and verify 

records

14
Mandatory Reporters

• Manufacturers

• 21 CFR 803.3(l)

• Importers

• 21 CFR 803.3(j)

• Device User Facilities

• 21 CFR 803.3(d)

15
Manufacturer

• Any person who manufactures, prepares, 

propagates, compounds, assembles, or 

processes a device

(21 CFR 803.3(l))

16
Manufacturer

Includes those who:

• Repackage a device

• Initiate specifications for a device

• Manufacture components or accessories that 

are ready to be used

(21 CFR 803.3(l))

17
Other Responsibilities of Manufacturers

• Investigate each event

• Obtain and submit missing information from 

other reporters

• Provide all information reasonably known

(21 CFR 803.50(b))

18
Other Responsibilities of Manufacturers

Information reasonably known:

• Obtained by contacting the reporter

• Obtained through analysis, testing, or other evaluation

• Such as professional, scientific, or medical facts, observations, or 

opinions 

• In the manufacturer’s possession 

(21 CFR 803.50(b))

19
Mandatory Reporters

• Manufacturers

• 21 CFR 803.3(l)

• Importers

• 21 CFR 803.3(j)

• Device User Facilities

• 21 CFR 803.3(d)

20
Importers

• Any person who imports a device into the United States 

AND 

• furthers the marketing of a device to the person who 

makes final delivery or sale to the ultimate user

(21 CFR 803.3(j))

21
Importers

• Do not repackage or change the container, 

wrapper, or label of a device or device package 

(21 CFR 803.3(j))

22
Other Responsibilities of Importers

• Responsibilities do not extend further than 

those required of all mandatory reporters

23
Mandatory Reporters

• Manufacturers

• 21 CFR 803.3(l)

• Importers

• 21 CFR 803.3(j)

• Device User Facilities

• 21 CFR 803.3(d)

24
Device User Facilities

• Hospital

• Ambulatory surgical facility

• Nursing home

• Outpatient diagnostic facility

• Outpatient treatment facility 

(21 CFR 803.3(d))

25
Device User Facilities

Are not:

• Physician’s offices

• School nurse offices

• Employee health units

(21 CFR 803.3(d))

26
Other Responsibilities

for Device User Facilities

• Submit annual reports to FDA (21 CFR 803.33)

– Form FDA 3419

– Form FDA 3419 instructions

27
How, When, and Where

to Submit MDRs

28
How to Report: Mandatory Reporters 

Manufacturers and Importers:

• Electronic submission only

• Electronic Medical Device Reporting (eMDR) Final Rule

– Issued August 14, 2015

• Use Electronic Submissions Gateway (ESG)

– eMDR Guidance

29
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

30
When to Submit

• After “becoming aware” of reportable adverse 

events and certain malfunctions 

– Within 30 calendar days

– Within 10 work days

– Within 5 work days

31
Becoming Aware

FDA considers a firm to be aware whenever:

• Any employee (or medical personnel) becomes aware of the 

reportable adverse event

• Any supervisory employee becomes aware the event 

requires remedial action to prevent harm to public health

21 CFR 803.3(b)

32
Remedial Action

• Any action other than routine maintenance or 

servicing of a device where such action is necessary to 

prevent recurrence of a reportable event

21 CFR 803.3(v)

33
Reporter: What to Report: Where to: When:

Manufacturers Deaths, serious injuries,

or certain malfunctions

FDA (3500A) 30 calendar days

Events requiring

remedial action

FDA (3500A) 5 work days

Importers Deaths or serious 

injuries

Certain malfunctions

FDA (3500A)

Manufacturer

Manufacturer

30 calendar days

30 calendar days

Device User 

Facilities

Deaths or serious 

injuries

FDA (3500A)

Manufacturer

10 work days

When and Where to Report

34
5-day Reports

• For events requiring remedial action to prevent an unreasonable risk of 

substantial harm

• When FDA has made a written request

21 CFR 803.53

35
Reporter: What to Report: Where to: When:

Manufacturers Deaths, serious injuries,

or certain malfunctions

FDA (3500A) 30 calendar days

Events requiring

remedial action

FDA (3500A) 5 work days

Importers Deaths or serious 

injuries

Certain malfunctions

FDA (3500A)

Manufacturer

Manufacturer

30 calendar days

30 calendar days

Device User 

Facilities

Deaths or serious 

injuries

FDA (3500A)

Manufacturer

10 work days

When and Where to Report

36
Reporter: What to Report: Where to: When:

Manufacturers Deaths, serious injuries,

or certain malfunctions

FDA (3500A) 30 calendar days

Events requiring

remedial action

FDA (3500A) 5 work days

Importers Deaths or serious 

injuries

Certain malfunctions

FDA (3500A)

Manufacturer

Manufacturer

30 calendar days

30 calendar days

Device User 

Facilities

Deaths or serious 

injuries

FDA (3500A)

Manufacturer

10 work days

When and Where to Report

37
Voluntary Malfunction Summary

Reporting Program (VMSRP) for 

Device Manufacturers

38
VMSRP for Device Manufacturers

• Final Rule issued August 17, 2018

• Grants an alternative for certain manufacturers to 

report certain malfunctions in summary format

• Reports are submitted electronically on quarterly basis

• Applies to malfunctions manufacturers become aware 

of after August 17, 2018

39
VMSRP Conditions

Summary reporting cannot be used if a reportable 

malfunction:

• Is associated with a 5-day report

• Is the subject of certain device recalls

• Involves a device deemed ineligible

‒ See Product Classification Database

40
VMSRP Conditions

Summary reporting cannot be used:

• If FDA has determined individual reporting is necessary

• Typically for public health reasons

• If FDA has determined a device manufacturer may not 

report in summary format

• If it is a new type of reportable malfunction for a device

41
VMSRP Reporting Schedule

Timeframe*: Submit to FDA by:

January 1 – March 31 April 30

April 1 – June 30 July 31

July 1 – September 30 October 31

October 1 – December 31 January 31

*Events manufacturers become aware of during this timeframe

42
Summary

• MDRs are required by FDA per 21 CFR 803

• Mandatory Reporters must understand and 

comply with reporting requirements

• MDRs are critical to public health and safety

43
Contact Information

Interpretations of MDR policy: MDR Policy Group

• Phone: (301) 796-6670 (voice)

• Email: MDRPolicy@fda.hhs.gov

44
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

45
Your Call to Action

• Stay current on MDR policies and regulations

• Establish your firm’s MDR procedures

• Be proactive and meet your reporting deadlines

46
47