- Guidance for Industry, User Facilities and FDA Staff: eMDR - Electronic Medical Device Reporting
- Final Rule on Electronic Medical Device Reporting (eMDR)
Electronic Medical Device Reporting (eMDR)
On Feb. 13, 2014, the FDA published a final rule on Electronic Medical Device Reporting (eMDR) that requires manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. The two options for submitting eMDRs are: eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR), which are described below. Both options are open to all reporters. User facilities can also submit eMDR reports following one of these options, but the final rule allows user facilities to continue to submit paper MDR reports. Manufacturers and importers will have until Aug. 13, 2015 to begin submitting all MDR reports electronically. If you are unable to meet this date, you must request and obtain an exemption from electronic reporting to continue to report via hardcopy past Aug. 13, 2015.
The FDA also released a Guidance for Industry, User Facilities and FDA Staff "Questions and Answers about eMDR- Electronic Medical Device Reporting" to answer questions related to FDA’s final rule requiring device manufacturers and importers to submit mandatory MDRs electronically.
Submitting electronic Medical Device Reports
The FDA has two options for manufacturers and importers to electronically submit MDRs, eSubmitter and HL7 ICSR. The eSubmitter application developed by the FDA can be used to send one report at a time (for low volume reporting). Alternatively, an entity can use the HL7 ICSR standard to develop its own application (for high volume and batch reporting).
FDA eSubmitter is a free downloadable application that allows submission of MDRs one at a time. This option is suitable for low volume reporters. The software contains data elements from the current MedWatch form and generates an HL7 ICSR message for each MDR the user generates using the software.
Please visit theFDA website for the eSubmitter software and instructions for installation.
Health Level 7 Individual Case Safety Reports (HL7 ICSR)
The HL7 ICSR submission method allows reporters to submit MDRs either as a batch or individually as XML files from their own complaint handling system. The HL7 ICSR messaging standard supports the exchange of electronic data and enables the extraction of information directly from the reporter's database to populate and transmit MDRs to FDA’s electronic secure gateway (ESG).
Please visit the FDA website for the HL7 ICSR implementation package
The FDA Electronic Submissions Gateway
eMDR uses theFDA Electronic Submissions Gateway, (ESG) an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The ESG serves as a highway, along which submissions travel to reach their designated FDA Center or Office.
Preparing to submit MDRs electronically to FDA
To submit MDRs electronically you will need to set up a Web Trader Account and then submit test data that is successfully processed through the FDA’s ESG before you receive a production account to use for your MDR submission. The steps you must follow are:
- Request a Web Trader Account from the ESG. Follow ESG instructions up to guidance compliance submission.
- Submit guidance compliance submission(s) and prepare a test eMDR for the scenarios specified below.
- Receive a production account from the ESG. (CDRH notifies the ESG once you have completed successful testing).
- Use the production account to send your actual eMDRs to the FDA.
CDRH eMDR Testing Process
After the receipt of your Web Trader Account, the ESG requires the submission of a connectivity and/or load test before testing with CDRH. The purpose of the tests is to ensure the connection with ESG is successful and ensure that you are able to send submissions. When you are ready to start testing with CDRH, please send an email to eMDR@fda.hhs.gov with your chosen submission method (see HL7 ICSR or eSubmitter testing scenarios below).
HL7 ICSR [High Volume/B2B (Business to Business information interchange)/AS2 (Applicability Standard 2 security specification) Partners]
The HL7 ICSR submission method has two testing phases: internal and formal. Internal testing is performed in-house to ensure major discrepancies are resolved before proceeding to the formal testing phase. During the internal phase notify CDRH with the report number and core-id (the ESG identifier from the third acknowledgment) related to the submission in question. In-turn, we will provide the pdf that is generated on our side for your content testing.
Below are the five formal testing scenarios that must be free of discrepancies in order to receive a production account. If a particular scenario does not apply to your reporting situation, please discuss with an eMDR team member. During the formal testing phase please provide us with the report number, core-id, xml and the pdf that is generated on your side for our content testing purposes. Once you have successfully passed the formal testing phase, we will notify the ESG to have your account promoted into production.
- 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 batch submission that includes more than one 3500A
eSubmitter [Low Volume WebTrader users]
Reporters who submit a small number of reports may opt to use eSubmitter. This submission method requires that you successfully submit a single testing scenario to CDRH. During this testing phase please provide us with the report number and core-id from the third acknowledgement (ACK 3). Once you have successfully passed, we will notify the ESG to have your account promoted into production.
- A complete initial 3500A
If you have questions or need further information, please write to eMDR@fda.hhs.gov