As of August 14, 2015, the FDA published a Final Rule: Medical Device Reporting; Electronic Submission Requirements requiring manufacturers and importers to submit their device MDR reports electronically to CDRH. Electronic reporting is also available to user facilities, but the rule permits user facilities to continue to submit written reports to the FDA.
This page provides detailed instructions for enrolling in the eMDR program to comply with the Final Rule. Submitters should read the information below carefully and transition to electronic reporting.
Low Volume vs. High Volume Submitters
eMDR and Electronic Submissions Gateway (ESG), an Agency-wide solution for accepting electronic regulatory submissions, support two different submission methods, which are commonly referred to as low-volume and high-volume. Each method has its own unique submission process, testing requirements, and account enrollment process; these differences are outlined below.
The first step of enrolling in the eMDR program is to decide which method of submission to use. Both options are open to all submitters.
Low-volume submitters report a new MDR electronically by using eSubmitter to create a MedWatch 3500A electronic submission zip file and then logging into the WebTrader internet site to submit the file.
High-volume submitters use their own AS2 gateway software systems to submit MDRs electronically.
Which method should I choose?
Submitters are free to choose whichever submission method best meets their needs. The low-volume submission method typically requires more manual action to file each report, but the high-volume submission method typically requires more effort to stand-up. The testing process is also much more intensive for high-volume submitters. While low-volume submitters use eSubmitter, which is supplied by the FDA, high-volume systems generate the files using their own system. Multiple test submissions can be used to validate that a high-volume system is generating the correct file. Once a reporter has decided which submission method to pursue, they should view the corresponding page to begin the enrollment process:
This outlines the enrollment process for new low-volume submitters. Each individual submitter should complete steps to comply with the Final Rule, even if other individuals in the same firm are already enrolled.
Note: This process applies only to submitters who use eSubmitter. If your firm uses custom software to generate the HL7 ICSR XML, enroll for eMDR using the high-volume enrollment process, regardless of whether you use WebTrader. Submitters should use this checklist to set up a WebTrader account.
Step 1: Obtain pre-production WebTrader account from ESG
- Visit the ESG account checklist page and begin the process outlined there.
- The ESG requires new enrollees to submit a letter of non-repudiation, register a digital certificate, and perform a connectivity test.
- Once you have reached step 4 in the ESG process (Prepare a guidance-compliant test submission), continue to step 2 below.
Note: If you already have a production WebTrader account (meaning that you were previously approved for production submissions other than eMDR), you may skip Step 1.Possessing a production WebTrader account is not approval to submit to production eMDR; you should still complete the enrollment process described below.
Step 2: Prepare a guidance-compliant test submission for eMDR
- Download the eSubmitter application and install it on your computer. You may see a screen requesting you register eSubmitter; however, registration is not required.
- Once you have eSubmitter installed, open the application and select Create New Submission > CDRH: MedWatch Form 3500A.
- Fill out the form completely, but describe a fictional adverse event. This information will only be used for testing purposes.
The quick guide will instruct you on the basics for using the application as each Center’s application differs slightly. For more specific information, please refer to the full length eSubmitter User Manual.
- When you fill out the report number, choose "MFR Report Number" in the drop-down box and include your firm’s real CFN or FEI in the "MFR Report Number" in the first part of the report number. If you have a 7-digit CFN, do not choose FEI and do not add three leading zeroes to the CFN number to make a 10 digit number. In the second part of the report number, use the current year. For the third part of the report number, use a five-digit number that has never been used for any MDR report, including paper. A sequence number with a high leading digit such as "70001" is best.
- When you have finished filling out the 3500A form in eSubmitter, click the Package Files button in the toolbar. In the dialog that appears, click Next > Next > Package Submission Files. This will generate a .zip file on your computer. This .zip file is the submission file that you will send to eMDR in Step 3.
Note: The eSubmitter .zip file contains both the HL7 ICSR XML for the report, as well as a PDF copy of the report. Windows Explorer has an issue with .zip files produced by eSubmitter, but you should be able to extract these files using third-party tools such as Winzip or 7zip. Low-volume submitters may want to save the PDF for their records. High-volume submitters may want to use the XML as a reference while developing their AS2 software.
- Once you have reached step 9 in the ESG process (Send a guidance-compliant test submission), continue to step 3 below.
Step 3: Send a guidance-compliant test submission to eMDR
- Log into the pre-production WebTrader site using the credentials supplied by the ESG. Go to the "Send document" page.
- On the submission page, under Routing Information, choose CDRH for the Center and Adverse_Events for the submission type. Use the "Add document" button to select the .zip file you created in Step 2. Select the certificate you registered with the ESG and provide your certificate password.
- Click Send button to send the submission.
- Wait 10 minutes after sending your submission, then go to "Sent Items" page. The file you sent should be listed. The same row should have three Acknowledgment links. Open Acknowledgement 3 and verify that the summary is "passed: 1, Failed: 0". If so, save the Acknowledgment 3 file onto your computer and proceed to step 4.
Note: If you do not see the third Acknowledgment link, 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.
If Ack3 contains an error message and says that "passed: 0, Failed: 1", reopen your submission in eSubmitter and correct any outstanding issues in the error message. Repeat steps 2 and 3 with the updated report information in eSubmitter. If you cannot fix the error, view the eMDR Help and Frequently Asked Questions page for troubleshooting tips.
Sometimes the Acknowledgment files appear out of order in WebTrader, so you may need to check multiple links until you find the Acknowledgment that indicates "pass" or "fail".
Step 4: Request low-volume eMDR approval
- Once you have successfully completed the guidance-compliant test submission, send an email to the eMDR Helpdesk (eMDR@fda.hhs.gov) and attach the Ack3 file you saved to your computer in Step 3. You will receive an approval email from eMDR instructing the ESG to grant your firm a production account.
- If this is your first time submitting to the ESG, you will receive an email from the ESG Helpdesk within 3 business days containing your production account information. If you do not hear back from them after making your successful guidance-compliant test submission, you may request support from the eMDR Helpdesk.
- If you already had a production WebTrader account, you can use your pre-existing account to submit to eMDR in the production environment. You will not receive any email notification from the ESG helpdesk, but your approval email from the eMDR helpdesk will serve as your go-ahead to begin submitting to production eMDR.
- Once you have your production WebTrader account, you are ready to submit real MDRs electronically as described in step 5 below.
Step 5: Send submissions to production eMDR
- To submit a real MDR electronically, create a new 3500A submission in eSubmitter and complete the form before packaging it as a .zip file, just like in step 2 above; however, you will use a normal sequence number (starting with 00001).
- Log into the production WebTrader site and send the file to eMDR, just like you did in pre-production WebTrader in step 3 above.
- View the Ack3 and save it for your records, as you also did in step 3.
- Repeat this process for each of your production eMDR submissions.
- View the eMDR eSubmitter and WebTrader tutorial video on how to prepare a low-volume submission for electronic medical device reporting (eMDR) and how to submit.
This outlines the enrollment process for new high-volume submitters.
Step 1: Begin software acquisition
- High-volume submitters should first decide whether to develop or purchase an HL7 ICSR XML and AS2 gateway software system. There are several relevant third-party software vendors, but the FDA cannot endorse a specific vendor or product.
- For firms that decide to develop their own systems, the eMDR implementation package describes the HL7 ICSR XML message expected by eMDR.
- The ESG guide describes the headers and other transport-layer configuration needed to submit a file through the ESG’s AS2 gateway.
- As soon as a project schedule is in place, submitters should continue to step 2 below.
Step 2: Schedule final high-volume testing and approval
- High-volume testing involves multiple guidance-compliant submissions, and each submission will be manually reviewed by a member of the eMDR helpdesk. To facilitate rapid approval of high-volume accounts, firms should send an email to eMDR@fda.hhs.gov notifying them of their intent to enroll as a high-volume eMDR submitter. The email should include a proposed date for final testing and approval.
- The date is not a hard requirement; if the submitter’s system is not ready on the proposed date, the final testing and approval can be delayed further. The purpose of requesting a specific testing date is for the firm to reserve approval time as early as possible, in the event that many submitters are seeking high-volume approval at the same time. The eMDR team will make best effort to approve all high-volume accounts at the requested time, on a first-come first-served basis.
- When the eMDR helpdesk receives the firm’s email, they will send an email response to confirm receipt. Once the confirmation email has been received, submitters should continue to step 3 below.
Step 3: Obtain pre-production ESG account
- All submitters are strongly encouraged to obtain a low-volume eMDR account before final testing and approval of their high volume accounts. To obtain a low-volume account, follow the process described on the eMDR low-volume enrollment section.
- Obtaining a low-volume account will allow the firm to use eSubmitter and WebTrader as a fallback in the event that the firm’s AS2 system experiences technical issues.
- Whether or not you choose to obtain a low-volume account, request a pre-production ESG account by following the steps on the ESG checklist. Once you have successfully obtained a pre-production ESG account, continue to step 4 below.
Step 4: Perform initial high-volume testing
- Using your pre-production ESG account from step 3, configure your AS2 software system to submit to pre-production eMDR. The ESG guide contains information on the required configuration parameters.
The pre-production eMDR system is always available for firms who are developing AS2 systems or software updates to test against. It may experience weekend downtime, similar to the production eMDR system. No approval is required to make test submissions to this system during development and deployment of your AS2 software.
- Continue internal testing and validate your AS2 system using pre-production eMDR until your firm is confident that your software is ready for production. When your system is ready to move to production, proceed to step 5 below to perform formal testing with eMDR.
Step 5: Submit final high-volume guidance-compliant tests
- When your firm is ready to submit the final high-volume tests, make the following submissions in the pre-production environment:
- A complete initial manufacturer MDR (fill every manufacturer report field)
- A supplemental MDR to submission #1
- An initial MDR with an attachment. This test is not required for firms with AS2 software that does not support attachments.
- A complete initial MDR user facility or importer report (F2 UF/importer report number filled, but sections G and H empty). This test is not required for firms that will never submit a user facility or importer report.
- A batch submission that includes more than one MDR in a single XML file. This test is not required for firms with AS2 software that does not support batch submissions.
Test submissions are only stored for two weeks in the pre-production environment, so you will not be able to use older submissions from your initial testing.
Once you have made all of the submissions, continue to step 6 below.
Step 6: Request high-volume eMDR approval
- Once you have made all of the submissions, send an email to the eMDR helpdesk containing all of the following:
- The report number for each of the final test submissions
- The core ID for each of the final test submissions
- A PDF, image, or other human-readable representation of each of the final submissions, generated by your system
- The eMDR team will manually review your test submissions and notify you to resubmit if there are any discrepancies. Once all concerns have been addressed, you will receive an approval email from eMDR instructing the ESG to grant your firm a production account.
- If this is your first time submitting to the ESG, you will receive an email from the ESG Helpdesk within 3 business days containing your production account information. If you do not hear back from them after making your successful guidance-compliant test submission, you may request support from the eMDR Helpdesk email@example.com.
- If you already had a production ESG account, you are now clear to use your pre-existing account to submit to eMDR in the production environment. Your approval email from the eMDR Helpdesk will serve as your go-ahead to begin submitting to production eMDR.
- Once you have your production ESG account, you are ready to submit real MDRs electronically as described in step 7 below.
Step 7: Send submissions to production eMDR
- Once you receive approval to begin high-volume submission to production eMDR, reconfigure your AS2 system to connect to the production ESG environment.
- Then begin submitting real MDRs using your AS2 softtware.