Electronic Medical Device 

Reporting (eMDR) Basics

November 4, 2014

Andrew Xiao

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

• Learn the basics of the Medical Device Reporting (MDR) 

Regulation

• Learn the basics of the “Medical Device Reporting: Electronic 

Submission Requirements Final Rule”

• Review the basic process for preparing and submitting 

electronic Medical Device Reports (eMDRs)

2
3

Medical Device Reporting 

(MDR) Regulation 

(21 CFR 803) 
Authority for Medical Device Reporting

• The Federal Food, Drug, and Cosmetic Act, Section 519 (Records 

and Reports on Devices) grants the FDA authority to require 

mandatory medical device reports from:

– Manufacturers 

– Importers

– Device User Facilities

• A report does NOT constitute an admission that the device, 

reporting entity, or the entity’s employee caused or contributed to 

the reportable event.

4
When do MDR Requirements Apply?

MDR Reportable Events: 

1. User facilities report when they become aware of information that 

reasonably suggests that a device may have caused or 

contributed to a patient death or serious injury.

2. Manufacturers or importers report when they become aware of 

events that reasonably suggest that one of their marketed devices:

– May have caused or contributed to a death or serious injury, or

– Malfunctioned and ... would be likely to cause or contribute to a 

death or serious injury if the malfunction were to recur.

5
Report Types and Timeframes

Mandatory reporting timeframes begin on the day after the 

user facility, importer or manufacturer becomes aware of a 

reportable event. 

Additionally, for manufacturers, the reporting timeframes for: 

• 5-day reports begin on the day after becoming aware of a 

request from FDA for 5-day reports or identification of a 

remedial action.

• Supplemental or Follow-up reports begin the day after a 

manufacturer acquires the additional/corrected information.

6
REPORTER WHAT TO REPORT WHERE WHEN

Manufacturer 

(Mfr.)

Deaths, Serious Injuries, 

Malfunction FDA Within 30 calendar days

Events that require 

remedial action to prevent 

an unreasonable risk of 

substantial harm

FDA Within 5 working 

days

Supplements (Follow-up 

Reports) FDA Within 1 month

User Facility Deaths FDA and Mfr.

Within 10 working 

days

Serious Injury

Mfr. 

(FDA if 

unknown)

Within 10 working 

days

Importer

Deaths and Serious Injuries FDA and Mfr.

Within 30 calendar 

days

Within 30 calendar 
8

Medical Device Reporting: 

Electronic Submission 

Requirements: Final Rule
eMDR Final Rule

• Requirements of final rule will take effect on Aug 14, 2015

• Manufacturers must submit initial and supplemental reports to FDA 

in an electronic format that FDA can process, review, and archive. 

• Importers must also submit initial reports to FDA in an electronic 

format.

• User facilities will continue to submit reports to FDA and the 

manufacturer in a paper format on FDA Form 3500A.

• The final rule does not change what must be included in a report or 

when the report should be submitted. 

9
eMDR Final Rule

Record Keeping Changes:

• Amends 803.18(b)(1)(ii) to require keeping copies of all reports 

submitted to FDA, whether paper or electronic (entities may choose 

method).

• Requires the retention of all acknowledgments that FDA sends to 

the manufacturer or importer (803.18(b)(1)(iii)). 

10
11

Electronic Medical Device 

Reports (eMDRs) to FDA
Electronic Submission Gateway

Electronic Submission Gateway (ESG)

• The FDA ESG is the central transmission point for 

sending information electronically to the FDA. ESG then 

relays the product specific report to the appropriate FDA 

center

• A secure entry point for all electronic submissions to the 

Agency.

• Digital certificate required for submitters.

12
Electronic Submission Gateway

• Acknowledgment 1: Indicates submission was received at the 

FDA ESG.

• Acknowledgment 2: Indicates submission reached CDRH.

• Acknowledgment 3: Indicates submission was successfully 

loaded into MAUDE or that submission contained errors.

• If there are no errors, the three acknowledgment letters will 

be generated within 24 hours of submission. 

13
Electronic Submission Gateway

• Contact the ESG Staff at ESGHelpDesk@fda.hhs.gov if the 

ESG system status website indicates the ESG is operating 

normally and you did not receive Acknowledgment 1 or 2.

• Contact eMDR@fda.hhs.gov if:

– the eMDR System Status website indicates that eMDR is operating 

normally and you did not receive Acknowledgment 3.

– help is needed to interpret Acknowledgment 3 error messages for an 

adverse event reports submitted to CDRH.

14
Web Trader

• Obtain a Web Trader Account from the ESG.

• Detailed instructions are accessible via FDA’s “Setting up a 

Web Trader Account Checklist” webpage.

• For policy questions and to request a WebTrader account, 

contact esgprep@fda.hhs.gov. 

• For assistance with the registration or testing process, 

contact ESGHelpDesk@fda.hhs.gov. 

15
eSubmitter 

• Standard software that eases the technical burden.

• This option is suitable for reporters that want to submit MDRs 

individually.

• Software generates an electronic version of Form 3500A in 

zip file format that is sent via ESG. Attachments can be 

included with submission.

• Please utilize the link in the “Resources Websites” section for 

the eSubmitter software and instructions for installation.

16
Health Level Seven (HL7)

• Standard for the capture of the information needed to support 

the submission of MDR reportable events.

• eMDRs can be submitted in large batches or one at a time.

• Allows for the extraction of information directly from the 

reporter’s database to populate an eMDR and for the 

transmission of the eMDR to the FDA ESG.

17
Health Level Seven (HL7)

• Firms may choose to develop a custom eMDR solution using 

HL7.

• Firms are encouraged to develop capabilities for saving and 

printing submitted reports and the submission of 

attachments. 

• Please utilize the link in the “Resources Websites” section for 

additional information regarding HL7.

18
Summary

• Please do NOT wait until August 14, 2015 to get an ESG 

account!

• The method for submitting MDRs to FDA has changed; other 

MDR requirements generally have not changed.

• eSubmitter & HL7 are two methods to submit eMDRs to FDA.

19
Resource Websites

• Draft Guidance Document: Medical Device Reporting for 

Manufacturers:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocum

ents/ucm359130.htm

• eMDR - Electronic Medical Device Reporting Guidance 

Document:

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocumen

ts/ucm175805.htm

• Medical Device Reporting: Electronic Submission 

Requirements Final Rule

http://www.gpo.gov/fdsys/pkg/FR-2014-02-14/pdf/2014-03279.pdf

20
Resource Websites

• Electronic Submissions Gateway (ESG) - System Status

http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm36754

5.htm

• eMDR System Status

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Postm

arketRequirements/ReportingAdverseEvents/eMDR%E2%80%93Electroni

cMedicalDeviceReporting/ucm179299.htm

• Setting up a WebTrader Account Checklist

http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm11483

1.htm

21
Resource Websites

• eSubmitter Download and Installation

http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm108165.htm

• Health Level Seven (HL7) Individual Case Safety 

Reporting

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance

/PostmarketRequirements/ReportingAdverseEvents/eMDR%E2%8

0%93ElectronicMedicalDeviceReporting/ucm127948.htm

• Medical Device Reporting (MDR) webpage

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

22
Providing Industry Education

Four Resources

1. CDRH Learn – Multi-Media Industry Education

§ over 80 modules

§ videos, audio recordings, power point presentations, software-based “how to” 

modules

§ mobile-friendly: access CDRH Learn on your portable devices

http://www.fda.gov/Training/CDRHLearn

2. Device Advice – Text-Based Education

§ comprehensive regulatory information on premarket and postmarket topics

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance

23
Providing Industry Education

Four Resources

3. Division of Industry and Consumer Education (DICE)

§ Contact DICE if you have a question

§ Email: DICE@fda.hhs.gov

§ Phone: 1(800) 638-2014 or (301) 796-7100 (Live Agents 9am – 4:30 pm EST)

Web Homepage: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ContactUs--

DivisionofIndustryandConsumerEducation/default.htm

24
Providing Industry Education

Four Resources

4. MDR Policy Group: Interpretations on MDR policy & 

requests for exemptions

§ Phone: (301) 796-6670 (voice)

§ Email: MDRPolicy@fda.hhs.gov

§ Or write to:

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

25
Thank you

26