DRAFT v1.1 (ed)
November 30, 2007
Table of Contents
- Section I: Introduction
- Section II: FDA eSubmitter Tool
- Section III: FDA Electronic Submissions Gateway (ESG)
- Section IV: Health Level Seven (HL7)—Standards Development Organization
- Section V: ICSR—Individual Case Safety Report
- Section VI: ICSR and eMDR
- Frequently Asked Questions
The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) initiated the eMDR (electronic Medical Device Reporting) project to enable industry partners to voluntarily submit medical device adverse event reports (MDRs) electronically. Phase I of the eMDR implementation will accept electronic reports via two options, one designed for low-volume reporting (few or infrequent reports) and one designed for high-volume reporting (numerous or frequent reports).
This document discusses the low-volume reporting option using FDA eSubmitter software. See the nearby link to Download and Installation for a detailed, step-by-step FDA eSubmitter user manual. Technical specifications for the high-volume reporting option may be obtained by sending an email to eMDR@fda.hhs.gov.
Geared for low-volume MDR reporting (few or infrequent reports), FDA's electronic submission tool—FDA eSubmitter—is a free downloadable program that enables program participants to electronically complete and submit MDR information using the MedWatch 3500A form. FDA eSubmitter provides the 3500A form in an electronic format. The FDA eSubmitter software provides:
- Tools to save address and contact information
- Product code searching
- Patient and device problem code searching
- Method, result, and conclusion code searching
- The option to attach documents when additional information needs to be provided
- A “missing data report” that ensures all required fields of the form are completed before submission to FDA. Once the report is completed with all the required fields, the files are “packaged for submission.” The package generates the 3500A form as a Health Level 7 (HL7) Individual Case Safety Report (ICSR) compliant XML document. By using FDA eSubmitter, participants generate a standard adverse event message effortlessly, without the need for special programming. (Sections IV and V provide more information on HL7 and ICSR.)
FDA eSubmitter uses the FDA Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The FDA ESG (also referred to as the ESG or the Gateway):
- Functions as a single point of entry for the receipt and processing of all electronic submissions in a highly secure environment that complies with secure messaging standards
- Serves as a conduit, or “highway,” along which submissions travel to reach their final FDA destination
- Automatically routes submissions to the appropriate FDA Center or Office
The electronic submission process through the ESG encompasses the receipt, acknowledgment of receipt (to the sender), routing, and notification (to a receiving FDA Center or Office) of the delivery of an electronic submission. Incoming submissions are processed as follows:
- The ESG receives an inbound submission.
- The ESG sends a Receipt or Acknowledgment 1 to the submitter; Acknowledgment 1 confirms the submission was successfully received by the ESG.
- The submission is automatically transferred to CDRH.
- Acknowledgment 2 is sent by CDRH to indicate the submission reached CDRH.
- CDRH validates and processes the submission.
- Acknowledgment 3 is sent by CDRH to indicate the submission is successfully loaded into the Adverse Event database or note any errors that occurred during validation and loading.
Reporters must register as trading partners with the ESG to send submissions electronically. See more information on ESG. The site contains an extensive manual to assist in understanding ESG requirements and a contact email address for questions about ESG.
Health Level Seven (HL7) is a not-for-profit volunteer organization. Its members all assist in standards development and include: providers, vendors, payers, consultants, Government groups, pharmaceutical groups and others who have an interest in the development and advancement of clinical and administrative standards for healthcare
HL7 is one of several American National Standards Institute (ANSI) accredited Standards Development Organizations (SDO) operating in the healthcare arena. Most SDOs produce standards (sometimes called specifications or protocols) for a particular healthcare domain such as clinical data, pharmacy, medical devices, imaging, or insurance (claims processing) transactions. HL7’s domain is clinical and administrative data.
HL7’s mission is to provide messaging standards for the exchange, management, and integration of data that supports clinical patient care and the management, delivery, and evaluation of healthcare services. Specifically, the organization works to create flexible, cost-effective approaches, standards, guidelines, methodologies, and related services for interoperability between healthcare information systems.
The HL7 ICSR message Release 1 (Normative Edition 2005) supports the exchange of data and other safety reporting requirements between various public health and patient safety organizations—specifically, reporting of adverse events or product problems associated with the use of drugs, therapeutic biologics, vaccines, and devices. Currently, work is under way to expand the scope of the message to support other types of products such as food, dietary supplements, cosmetics, or veterinary products and services.
The ICSR message is specifically designed to support individual case safety reports and does not support population-based case reporting for disease surveillance or outbreak events. The message can support international safety reporting between public health organizations.
The eMDR project adopted the ICSR standard to receive and MDR information electronically. Only portions of the ICSR that relate to device adverse event reporting are implemented via eMDR. The ESubmitter software generates the 3500A form as a Health Level 7 (HL7) Individual Case Safety Report (ICSR) as a compliant XML document.
How is the eMDR project related to the FDA ESG?
All electronic submissions to FDA must come through the ESG. You must purchase a digital certificate and register as a trading partner with FDA. Once registered, you can submit electronic MDRs via the ESG. See more about ESG.
How will our submissions reach CDRH?
Electronic MDRs will be routed from the ESG to CDRH. Once in CDRH, the eMDR software will load your submission into the appropriate database.
How will we know our submission reached CDRH?
You will get three acknowledgments when you submit your MDR electronically. Refer to Figure 1 , Inbound Submission Processing by FDA ESG.
Acknowledgment 1 (also referred to as Receipt): sent by the ESG; confirms the submission was successfully received by the ESG. Below is an example of Acknowledgment 1.
This MDN (Message Disposition Notification) was automatically built on Mon, 12 Mar 2007 20:18:17 GMT in response to a message with id <4655498.1173730688677.javamail.irk@drl5120769> received from ZZFDATST on Mon, 12 Mar 2007 20:18:10 GMT. Unless stated otherwise, the message to which this MDN applies was successfully processed.
Acknowledgment 2: sent by the ESG; indicates the submission reached CDRH. Below is an example of Acknowledgment 2.
DateTime Receipt Generated: 03-12-2007, 16:21:18
CDRH has received your submission
Acknowledgment 3: sent from CDRH; indicates your submission is successfully loaded or notifies you of any errors that occurred during validation and loading. Acknowledgment 3 is sent as an HTML (hypertext markup language) file.
What happens when Acknowledgment 3 notifies of errors in submissions?
If you submit an electronic MDR and you get an error message in Acknowledgment 3, please correct the errors and resubmit the submission. When you resubmit the MDR, you will get another set of acknowledgments.
What is the time frame to receive these acknowledgments?
You should receive your acknowledgments quickly after your submission unless ESG is down for maintenance. For the ESG status, please check the ESG Web site.
Does the size of my submission matter?
Delivery and processing time is dependent upon the overall size of your submission; larger submissions will take longer to be delivered and processed.
Is there a recommended time of day to send submissions?
Submissions can be transmitted at anytime via the ESG. Please refer to the ESG Web Site for information on maintenance and down-times.
What about scheduled maintenance and system down-times?
The various systems used to process electronic MDRs are independent of each other with regard to scheduled maintenance and down-times (please refer to Figure 1: Inbound Submission Processing by FDA ESG). The system that is down determines what happens to your submission.
The ESG is down: If the ESG is down, acknowledgments 1 and 2 will be delayed. Your submission will not reach CDRH for processing via the eMDR system. For more information on ESG maintenance and down-time, see the ESG Web Site.
eMDR system is down: If the eMDR system is down, acknowledgment 3 will be delayed. If the eMDR system is down, but the ESG is functional, your submission will be routed to CDRH, and you will receive acknowledgments 1 and 2.
Are there any formatting requirements for filenames submitted via eMDR?
Please make sure filenames do not contain periods except to indicate the file extension. Due to the way filenames are read, once a period is encountered, the rest of the filename is considered the file extension. For example, a filename such as “5555555555.5555.5555.xml” will be read as filename “5555555555.55555555xml.” This will result in our not being able to open and read the file properly, so please only include periods in a filename to indicate file extensions.
Will requests for additional information from CDRH come to us via the ESG electronically?
No, at this time the ESG is not set up to handle outgoing requests for additional information. You will receive any request for additional information by mail in keeping with our current practice.
Are there any special requirements for digital certificates to submit via the ESG?
Please see the FDA ESG User Guide at the ESG site for more information on digital certificates.
Who do we contact for questions regarding the FDA ESG?
For questions regarding registration, setup, policy, and so on, please write to firstname.lastname@example.org
Can we install FDA eSubmitter on a network?
Yes. The software can be installed anywhere and will work properly. The file-locking option can be used to prevent users from accidentally overwriting the work of another. For details, see Networking in Preferences in the FDA eSubmitter User Manual.
We have a PDF we want to include. Can we add it to the WinZip file generated by FDA eSubmitter?
No. Do not modify the file after it is generated by FDA eSubmitter. If you do, your submission will fail our loading process. Always attach the desired PDF to the appropriate question using the FDA eSubmitter software. Repackage your files and resubmit your submission to FDA.
Can we submit multiple patients or devices per MDR report?
No. The current version of FDA eSubmitter allows only one patient and one device per MDR report; that is, each report may have only one Section A and one Section D.
How do we report supplemental or follow-up information?
For supplemental information, only submit new or updated information. Do not resubmit information provided with your initial MDR submission. Make sure you denote the report as a follow-up in Section G7, and provide a follow-up number.
New and updated information that can be provided as discrete data elements on the 3500A form should be reported in the appropriate sections. For example, if you would like to add/append/change device problem codes, please do not include that information as part of Section H10. Instead, include it in Section F10 where you would normally provide device problem codes. Provide new or updated text narrative under the appropriate sections of the MedWatch 3500A form using FDA eSubmitter.
How do we ‘blank-out’ something we submitted in an initial? For example, field D4, Other Number, was submitted as ‘ABCD’ in the initial report. In the supplement, we want to ‘remove’ or essentially ‘blank-out’ that value. How do we do that?
Current system design calls for only NEW or UPDATED information to be submitted via a Supplement. Therefore, a ‘blank’ or ‘null value’ submitted in a field will be interpreted as no change from the initial report, so the database will not be updated for that field. Please use field H10 to explain the change or indicate the change for the field.
Can I respond to an FDA Request for Additional Information electronically?
Yes. Responses to FDA’s Request for Additional Information can be reported under MedWatch 3500A, Section H10. This includes all discrete data elements. Note that this is different from how supplemental reports are submitted (refer to question above). You may submit the letter you received as part of the attachment to the message.
Make sure you denote the report as a follow-up in Section G7, and provide a follow-up number. Indicate the follow-up is due to a Response to FDA Request in Section H2.
How do we submit attachments?
You can submit attachments electronically using the FDA eSubmitter application. Refer to the FDA eSubmitter User Manual.
How do we submit the adverse event information from the initial reporter, such as a User Facility (U/F) importer or voluntary reporter?
Depending on the source of the initial report, you may submit the source report information as follows:
- User facility or importer report – Include report information by populating the appropriate fields of the 3500A using FDA eSubmitter (i.e., populate all sections of the message pertaining to MedWatch 3500A Section F).
- Voluntary report – Submit this as an attachment to your electronic MDR.
If you have more than one source report for the event—that is, both (1) and (2) as described above—include one report as part of your electronic MDR, and submit the other(s) as attachment(s).
How do we go about setting up for testing with the eMDR system?
eMDR utilizes the FDA Electronic Submissions Gateway, an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The Gateway authenticates and validates electronic submissions and routes it to CDRH. After registering with the FDA Electronic Submissions Gateway as a trading partner, one of the requirements for an ESG production account is to submit a guidance complaint submission to CDRH. The purpose of testing is to catch any issues early on, so once you transition to electronic reporting, there are no major problems due to improper formatting or incorrect values in the submission. When you are ready to send a guidance compliant electronic MDR submission, please send the below test reports (based on your submission method) to the test ESG account.
Can we send test submissions through the Gateway?
Yes, but you need to notify the eMDR team via an email to eMDR@fda.hhs.gov.
What data can we use for testing?
All test reports are loaded to our test database. This will not be released to the public at any time. You can submit ‘made-up’ data for testing or use data from a prior 3500A. To ensure that your report does not get rejected because a duplicate report is present in our system with the same report number, please use a leading 7 in your sequence number. Example -- CFN-YEAR-70001 or FEI/CMS-YEAR-7001.
How many reports are required for testing?
The purpose of testing is to catch any issues early on, so once you transition to electronic reporting, there are no major problems. Testing will continue until all issues are resolved satisfactorily. Issues can arise as a result of improper formatting, validation failures, etc.
When you are ready to send a guidance compliant electronic MDR submission, please send the below (based on your submission method) to the test ESG account.
For High Volume/B2B/AS2 Partners:
- A complete Initial 3500A
- A complete Initial 3500A with an attachment
- A complete Initial 3500A followed by a supplemental 3500A (supplemental to be submitted after initial is loaded successfully)
- A complete Initial 3500A with section F filled out (section F is used to provide information from user facility or importer source report)
- A complete Initial 3500A and source report(s)
For Low Volume/WebTrader users:
- A complete Initial 3500A
Once you have your electronic MDR as determined by your submission method above, please send an email to eMDR@fda.hhs.gov with the report number and core-id from the third acknowledgement. Once CDRH verifies the submission(s) are loaded into the FDA database properly, we will notify the ESG to give you a production account.
If you would like to submit additional report scenarios as a test, please contact an eMDR team member at eMDR@fda.hhs.gov.
Who should we contact with questions?
For general questions on eMDR, please email eMDR@fda.hhs.gov