eSubmitter and WebTrader tutorial video script

Video #1:

This video will demonstrate how to prepare a low-volume submission for electronic medical device 

reporting (eMDR) using eSubmitter software or eSubmitter. It was created by the staff from the MDR 

Team supporting the eMDR Helpdesk to assist those who submit low volume of MDR reports 

electronically to CDRH. 

Video #2:

To begin, you should have eSubmitter installed and opened on your computer. To download eSubmitter 

application go to https://www.fda.gov/industry/fda-esubmitter . Registration of eSubmitter is optional; Click, 

“Register later”.

Video #3

From the eSubmitter “Welcome” Screen, click on the “Create New Submission” button under the “Menu 

Options” section. The first step is to select the appropriate submission type from the list of available options.

eSubmitter is available to users for a variety of submission types. Scroll down and then select CDRH 

MedWatch Form 3500A. Once highlighted, information appears in the “Description of Selected Submission 

Type” dialog window about the selected form. Click “Next.”

Video #4:

The second step is to provide a “Descriptive Name” and “File Name” for the submission, both of which are 

required fields. Please note that the blue dot next to certain fields denotes that such information is required 

to complete the submission. Other fields without the blue dot indicate optional information. The

“Descriptive and File name” used are intended for you to use to organize the eSubmitter files. FDA will 

index the files by “core ID” and “report number’ when they are received. Submission files should be 

named appropriately so that you can recognize the submission by its name to reopen it later, if needed. For

purposes of this tutorial, we will name this submission “Sample3500AForm”. Click “Create.”

Video #5:

At the bottom of the screen there is a navigational bar which allows the submitter to click a left facing arrow 

to return to the previous screen. The “outline view” allows you to return to the list of fields. The right facing 

arrow allows you to proceed to the next screen. 

Click “Next.”
Video #6:

From the drop-down arrow in the grey box located on the right-hand side of the “Report Number” screen

select the option that best describes you as a submitter. The options include “manufacturer,” “User Facility,” 

and “Importer.” If you are a manufacturer Select “MFR Report Number,” select “User Facility Report 

Number” if you are a user facility, or if you are an importer, then select “Importer Report Number.” For

MFR or importer report number, please select “CFN” if your firm’s registration number is 7 digits long. If 

your firm’s registration number is 10 digits long, you should select FEI. For User facilities, please use your 

10 digit Centers for Medicare & Medicaid Services (CMS) number, followed by a 4 digit year, followed by 

a 4 digit sequence number. For the purpose of this tutorial, we are selecting “MFR Report number” and 

entering a MFR report number. 

Complete the fields named “Form Code” and “Exemption Number” if FDA assigned you a form code or any 

type of exemption. Click “Next.”

Video #7

On the “Patient Information” screen, enter all patient information in Part A. click “Next.”

Video 8

Complete the information requested for the fields on the “Adverse Event or Product Problem” Screen, Part B

(B1 to B4). Enter all the information that is available. click “Next.”

Video #9

Complete the information requested for the B5 field named “Describe Event or Problem.” The completion of 

this field is required. For example: It was reported that the pump had a broken display. No adverse patient 

effects were reported. Click “Next.”

Video #10

Complete B6 field named “Relevant Tests or Laboratory Data” screen. Enter all information that is available. 

click “Next.”

Video #11

Complete, B7 field named “Other Relevant History.” Enter all information that is available click “Next.”

Video #12:

On the “Suspect Products” screen, select “No“ in response to the question “Is this a combination product?”

then proceed to Section D. If the response is yes, this action enables the questions in Section C, named 

“Suspect Products information.” For the purpose of practicing, we select “Yes”. Click “Next.”
NOTE: By selecting 'Yes' to this question you are declaring that the product that was involved in the Adverse 

Event is a of Combination Product, and the corresponding checkbox in Section G4 of the report, will 

automatically be checked and you will not have the ability to edit it. To be able to remove the selection from 

the “G4 Combination Product” checkbox, you must select 'No' in response to this question.

Video #13

Enter information related to “suspect product” in fields C1 through C9. The green plus (+) button allows you 

to enter more than one suspect product. Drug Sequence Number is required. Enter 1 for your first suspect 

product. If your suspect product is a drug, a maximum of 20 suspect drugs can be added to a submission. 

Click on the yellow bulb to display the hint for drug sequence number. The next yellow bulb displays the hint

for drug dose. Click “Next”. A dialog box appears, and you will be given an option to add another suspect 

product if any. If not, then to move to the next screen. Click “ok”.

Video #14

Since in our example, we don’t have any “Suspect product information” to include, we will go back to the C 

section to select “No” in response to the question “Is this a combination product?” Click on “Previous” and 

delete the item we just created by clicking on the “Delete Item” button. A dialog box appears to confirm your 

deletion. Click “Yes” then click “Previous” to go back to the “Suspect Products” screen. Select “No” in 

response to the question “Is this a combination product? “and then click “Next”, which takes you to a new 

screen named “Suspect Medical Device” (D1 – D2). Please note that D2, “Common Device Name” and “Device 

Product Code” are required fields for mandatory reporters and should be completed. In our example, FRN is 

the product code I’ll use. You’ll notice that the device information pops up if the product code is correct. If 

you don’t know the device’s product code, you can search it by clicking on the green plus button located 

on right-hand side and it will take you to the product code filter dialog box where you can search for a 

product code and select the corresponding product code for the device. Click “Next.”

Video #15

On the “Suspect Medical Device” (D3) screen, enter the corresponding manufacture’s name, address and 

phone number. click “Next”.

Video #16

On the “Suspect Medical Device” (D4 – D6) screen, enter “Additional device information”, “Operator of 

Device” and whether the device was “implanted or explanted including the dates.” Click “Next”

Video #17

Continue completing Fields D7– D9 on this screen. Click “Next”

Video #18
Complete D10 by providing information related to “concomitant Medical Products” and “Therapy Dates.” 

Concomitant products are any other medical products (drugs, biologics, including human cells, tissues, and 

cellular and tissue-based products, or medical devices, etc.) that the patient was using at the time of the event. Do 

not include products used to treat the event. Click “Next”

The “List Data Message Dialogue” box appears. Select the appropriate button to add another item or to 

move to the next screen. Then Select “Ok”.

Video #19

Complete the information about the Initial Reporter in Part E1 of this screen. Provide the name, email address, 

mailing address, and phone numbers of the person who initially reported the adverse event to the user facility, 

manufacturer, or importer, and who can be contacted to provide information on the event if follow-up is 

necessary. Once completed, click Next 

Video #20

Include a response to Answer the questions in the E2 and E4 fields. Select the appropriate response for the 

question in the E3 field using the options from the dropdown menu located on the righthand side. Click Next

Video # 21 Section F (F1 – F14) is only used by User Facility or Importer.

You will notice There is no Section F. that is because section F is only used by User Facility or Importer.

Video #21

Section G is required for Manufacturer submitters. The G1 field pertains to information that identifies 

the “name and contact information for the contact office (and manufacturing site for devices”) or 

“compounding outstanding facilities.” click “Next”

Video #22

This screen is a continuation of the G1 field, which is intended for information about “office contact” or 

“manufacturing site.” After completing this screen, click “Next”

Video #23

Manufacturer submitters would complete the G2 and G3 fields on this screen. The G2 field identifies the 

“report source”. The submitter would select the appropriate box to identify the source from which the 

manufacturer learned about the event that is the subject of the report. The submitter must select from 

the list provided. If the source is not listed, then they should check the box identified as “Other” and 
include such information. The G3 field should be completed with the “date the manufacturer received 

the information or learned about the event” from the source identified. click “Next”

Video #24

Manufacturer submitters would complete the G4 and G5 fields on this screen. The G4 field named 

“Premarket Identification” includes a list of premarket submission information/ types. The fields related 

to the suspect product identified in section C are not filled on this screen; instead, they are filled for each 

suspect product on the screen for section C. You should fill the Device BLA and PMA/510k fields with 

identifying information pertaining to the suspect medical device described in section D. Click “Next”

Click “Next” 

Video #25

Manufacturer submitters would complete the (G6-G8) fields. The G6 field, is intended for all 

(manufacturer) reports. Medical device manufacturers must identify the report as “initial,” “follow up or 

5-day reports.” If the report submitted is a “follow up” report, the submitter must identify the 

appropriate sequence of follow-up to that particular initial report (e.g., first follow-up report = follow-up 

#1, second follow-up report = follow-up #2, and so on). If the report represents an event that must be 

reported as a 5-day report, then the submitter would select the corresponding 5-day box. The remaining 

values are available for Drug sponsors and for the reporting of Combination Product reports. In this 

example, we are checking the initial box, because it is our first submission, not a follow up.

Complete the G7 field, if applicable. This field is used for drug and biologic, including human cell, tissue, 

and cellular and tissue-based product (), manufacturers only.

The information for the G8 field was previously provided on the “Report Number” screen. Therefore, no 

entry is required. Click next 

Video #26

Part H is required to be completed by device manufacturer submitters. The H1 field identifies the “type of 

reportable event.” This is a required field and must be completed. The submitter must select from the 

options listed. The options include “Death,” ”Serious Injury,” and “malfunction.” If the type of report 

represents a “summary report,” then the “summary report” box must be selected, and the “total number of 

events being summarized” must be entered in the corresponding available field. For example, if the report 

represents a malfunction report that summarizes 500 individual events, the submitter will check the 

“malfunction” box and the “summary” box. The submitter would also enter the value 500 to identify the total 

number of events being summarized. If the report represents an individual event, then the “summary report”

box remains unchecked. Since our example does not represent a “summary report,” we’ll uncheck the 

“summary report” box.

The H2 field pertains to the “type of follow up” and should be completed for supplemental reports. Check the 

box(es) that most accurately describes the nature of the follow-up report.
The H3 field identifies whether the device subject of the report was evaluated by the manufacturer. Click

“Next”

Video #27

Complete the H4-H6 fields. The H4 field pertains to the date the device was manufactured. 

The H5 field is intended to identify whether the device is labeled as “single use.” The submitter should check 

the box that provides the answer to the question. 

The H6 is intended for documenting the codes associated with the “Adverse Event Problem” and 

“Investigation.” The submitter should click on the green plus buttons under each corresponding field to select 

the code that appropriately identifies the event being reported. For “Adverse Event Codes,” please refer to 

the FDA’s Medical Device Coding Resources page at https://www.fda.gov/medical-devices/mdr-adverseevent-codes/coding-resources . click “Next”

Video #28

Complete the H7-H9 fields. The H7 field pertains to identifying the type of remedial action, if one was 

initiated. If applicable, the submitter would make a selection from the list provided. 

The H8 field is intended to identify the usage of the device. The submitter should select from the list 

provided. 

The H9 field, pertains to actions reported to FDA under Corrections and Removals. If applicable, then the 

submitter should indicate the reporting number for such action. click “Next”

Video #29

The H10-H11field is intended to allow the manufacturer to provide additional narrative or additional data 

related to the event that is the subject of the report. The information included in this field should not be 

duplicative of information included in other sections of the report being submitted. 

Click” Next”

Video #30

This is the File Attachments screen where you can attach additional information that would help FDA 

understand the circumstances related to the event and the device involved. To add attachments to a report, 

the submitter should click on the green plus button located on the left-hand side of the screen. Follow the 

prompts for uploading the attachments. After attachments have been uploaded, Click “Next”

Video #31

· You have finished the process for the completion of the report Submission. If the report was not 

successfully completed, you will receive a “Warning” pop up box that will alert you that there is data 
missing that should be provided for processing the report. When this happens, you will not be able 

to package a submission file to submit a report to FDA. You must complete the missing information 

before proceeding. Click “Close”

· To identify the fields that need to be completed, select the “Missing Data Report” from the “Output 

menu” located on the Toolbar at the top of the screen. 

· Click “Ok” to open the Missing Data Report. Here the report lists two missing data: Report Number 

and D section. Close the page.

· Another way to identify which fields need completion is by clicking on the “Outline View” button

located at the bottom of the screen. 

Video #32

· The required Missing data fields will be identified by a question mark (?) next to the missing data

field. In our example, the first missing data requires to be completed before packaging is the “Report 

Number”, as it is identified by the question mark.

· Highlight the report Number and click “Select” at the bottom of the screen to complete the specific 

data field.

Video #33

· In this example, the “Sequence Number” was omitted. This is a required data field, as indicated by 

the blue dot. Add the “Sequence number”. click Next.

Video #34

· Click on “Outline View” button again. to identify the next required missing data. Select the next 

missing data (D.Suspect Medical Device (D1-D2)) by highlighting it and click on “Select.”

Video #35

· The “Common Device Name” is a required data field. Therefore, it must be completed. Infusion 

Pump is the common name in our example. click “Next”

Video #36

· Click on the “Outline View” button again to identify the next missing data field. Do the same until all

missing data fields have been completed. 

· Once you have completed all the required missing data fields, the system will allow you to package 

your file. 

· Click on the “Package Files” button from Icon tool bar located at the top of the screen.
Video #37

· The Packaging Files Dialog box will appear. The packaging process will result in a single ZIP file per 

submission. The ZIP file generated by eSubmitter should not be altered in any way prior to 

transmitting to FDA. 

· Note: The Package Output Location, located on the bottom of the dialog box, indicates the 

folder on your computer where the zip file will be saved. You will need to access the file from 

that location at a later time. For additional instructions, select the yellow lightbulb in this dialog 

box.

· Click “Next” in the “Packaging Files Dialog” box. Click “Next” again and then click the “Package 

Submission Files” button to complete the packaging. Click “Next” again in the dialog box.

· You will receive the message “Submission Package Created Successfully.” Click “Done.”

Video #38

· To submit your zip file to CDRH, you need to login to your WebTrader account. The next video will 

walk you through that process.

How to send a Low-Volume submission to eMDR using WebTrader

Video #39:

This video will demonstrate how to submit a low-volume eMDR using WebTrader. It was created by 

the staff from the MDR Team supporting the eMDR Helpdesk to assist those who submit MDR reports 

electronically to CDRH. 

Before sending a WebTrader test submission, ensure you have setup your WebTrader test account 

using the instructions located at https://www.fda.gov/industry/create-esg-account/setting-webtraderaccount-checklist.

Video# 40:

In order to send a submission using WebTrader, please perform the following steps:

1. Go to the Electronic Submissions Gateway (ESG) test login screen at https://esgtest.fda.gov/

a. Enter your User ID

b. Enter your Password

c. Click the check box next to “I agree to the terms set forth in the Rules of Behavior. and 

click the “Log in” button

A welcome dialog box will appear, please review the messages and click the “Close” button.
Video #41:

To create a submission, click the “Send Document” button located in the left-hand window frame:

On the Send Document page, perform the following steps: 

a. Select CDRH for Center

b. Select Adverse-Events for Submission Type

c. Click on “Add documents” to locate the zip file you produced by eSubmitter to be 

uploaded. Click “Select”

d. Select the signing certificate by clicking on the Signing Certificate link. If you have already 

selected your certificate, it will be displayed on the send screen. If this is your first 

submission, you will have to click the link and locate it on your computer.

e. Enter the signing certificate password (this was provided when you created your ESG 

account)

f. Click the “Send” button

You will receive a message at the top of the screen indicating your upload has been added to the queue. 

At the bottom of the screen you will see the message, “Uploads in Progress”.

Wait approximately 10 minutes after sending your submission, then go to "Sent Items" page to confirm 

that your submission was received.

Video #42:

On the Sent Items page, you will find the zip file you just submitted with an Acknowledgments bar on 

the same row. 

*Note: You will get three acknowledgments when you submit your MDR electronically. 

Acknowledgment 1 (also referred to as Receipt) is sent by the Electronic submission Gateway or ESG and 

confirms that the submission was successfully received by the ESG. Acknowledgment 2 is sent by the 

ESG and indicates that the submission reached CDRH. Acknowledgment 3 is sent from CDRH and 

indicates that your submission was successfully loaded or notifies you of any errors that occurred during 

validation and loading. If the submission was successfully loaded, your "passed" acknowledgement3

serves as proof that your submission was received and accepted by eMDR.

**Note: If you do not see the 3 Acknowledgments, please wait up to 24 hours and check again. If there 

is no Acknowledgement after 24 hours, follow the instructions on the eMDR Help and FAQs page to 

request support.

Click on the zip file to open all the Acknowledgements (ACK)s. In the Document Details box, ACK3 is 

provided in both HTML and XML formats; ACK2 usually appears under ACK3 in a text format, and ACK 1 

appears under ACK 2 as RECEIPT. Please note that sometimes ACKs are displayed in different order. In 

our example, ACK2 is the first acknowledgment from the top.
Please note that the 3 Acknowledgment files you receive in Webtrader are your proof that the 

submission was received. However, you need to read ACK3 to determine if your report “passed” or 

“failed”. You should save the passed/successful ACK3 for all your submissions in your firm’s reporting 

records.

If your submission failed, you will see an error message describing the issue. You should reopen your 

submission in eSubmitter, correct the issue, repackage and resubmit. You will then receive a new series 

of ACKs.

Let’s review the ACK3 file. Open the ACK3 in the html format by clicking on the down arrow to 

download it; save it on your computer and then open to read. 

In the Submission Summary box, the Summary Line indicates that your submission “passed”. If you open 

ACK3 in the xml format, you will see the same message but in a different format.

Let’s now open ACK2 file and review the message it provides. You can view, download or print ACK2 file. 

Click on “Download arrow” and open to read. ACK2 will only state that “CDRH has received your 

submission” but won’t indicate whether your submission passed or failed. So, it is important to always 

save and read ACK3 to ensure your submission passed.

Video #43

Once determined that your report has passed, you will then need to send the successful ACK3 to the 

eMDR helpdesk emdr@fda.hhs.gov and request approval for a production account. If you need further 

assistance, please contact the eMDR helpdesk at emdr@fda.hhs.gov.