02 Apr Counting Down: eMDR Compliance Deadline is Fast Approaching
As most companies and individuals in the Medical Device Industry are aware, on February 13, 2014 the FDA published a final report requiring manufacturers and importers to submit all Medical Device Reports (MDRs) in electronic format. The compliance date of August 13, 2015 is fast approaching (1). It is best to not wait until the last minute to prepare for this new mandate.
Updating an Outdated System
The first MDR regulation was released in 1984. Since then it has undergone numerous amendments, however the format for submission (paper versus electronic) has not been changed. This means that in over 20 years, MDRS have been submitted in paper format (1). In an age of technological advancement, it stands to reason that adverse event reports are now being required to be submitted in electronic format. The FDA hopes this change will enable them to more effectively collect and analyze the adverse events being reported to better evaluate device safety and effectiveness (2). The final rule applies to manufacturers and importers, and although it is not required of user facilities, the option is still available (1).
The Who, What, When, and How of the Final Rule
The eMDR final rule applies to reports of death, serious injuries, and device malfunctions. Both Manufacturers and importers must submit these reports to the FDA according to the following timelines and on the appropriate forms. Even though user facilities to not need to comply with the electronic submission requirement, there are still reporting requirements they should be aware of. Different requirements also apply to manufacturers and importers (3).
Take the Necessary Steps towards Compliance
It is important to become familiar with the different programs that will be used to submit Electronic Medical Device Reports (eMDRs) to the FDA. When first reading through the resources the FDA provides that describe eMDR software and websites, compliance with the final rule may seem impossible. Following the steps below will help you avoid being inundated by the information presented.
ESG, eSubmitter and HL7
As explained in the FDA’s Electronic Medical Device Reporting Guidance, eMDRs will be submitted to the FDA through the Electronic Submissions Gateway (ESG). There are two options for preparing the eMDR submissions; one is for low-volume reporting (eSubmitter) and one for high-volume reporting (HL7).
The eSubmitter is a FDA developed software that enables users to create and submit reports one at a time using the 3500A form. This program is free to install. You should follow the steps below to prepare for submission of eMDRs to the FDA. You can Download the eSubmitter Software, and create a training “eMDR” to familiarize yourself with the software. The eSubmitter does not actually submit the eMDRs, however it is the tool you use to format the reports before they are submitted to the ESG.
Health Level Seven (HL7) Individual Case Safety Report (ICSR)
HL7 ICSR is used for manufacturers and importers who need to be able to submit multiple or single reports. Information is extracted from the reporter’s database and submitted as an XML file and transmitted to the ESG as Medical Device Reports (1). A series of test submissions must be completed before a reporter can be granted an account to submit HL7 ICSRs through ESG. (2)
The Electronic Submissions Gateway (ESG)
Once you have selected a submission method, it will be necessary to set up a Web Trader Account. This is essentially an account for your company to submit electronic reports to the FDA. Test reports will need to be submitted in order to receive a production account. In order to do this you will need to:
- Email ESGHelpDesk@fda.hhs.gov and inform them that you want to register for the ESG. They will provide you with the web interface address and a temporary login ID and password (this is to be used to submit a test report).(6)
- Submit a Letter of Non-Repudiation Agreement that states that all electronic signatures are legally binding. Click here for sample letters and directions. (6)
- Obtain a personal digital certificate for electronic signatures. The FDA recommends that organizations obtain certificates that are valid for three years(4). You can use the following companies to obtain a certificate:
- Submit a test report to the FDA ESG. Do this by logging into the ESG with the temporary login and password and preparing and submitting a “mock” eMDR 3500A Form (6).
- If there are no issues with the Mock eMDR submitted to the ESG, the FDA will issue a production account for the ESG. You will use this account to send real eMDRs to the FDA.
Update Post-Market Procedures
In order to be compliant with the FDA’s final rule, it is not simply enough to submit reports in electronic format. Manufacturers will also need to update, or develop from scratch, procedures for identifying adverse events that are reportable and subsequently reporting them in eMDR format (9).
Maintain a Complete Record
The final rule dictates that two kinds of files be established and maintained. First, files for all complaints relating to medical device adverse events should be kept up to date (5). Second, copies of all eMDRS submitted to the FDA and all FDA acknowledgements of these reports should be kept, either in paper or electronic form (2) (5).
The Countdown Begins
All manufacturers and device importers are required to meet the eMDR requirements, and this includes foreign manufacturers who export devices into the U.S. It is essential that manufacturers and importers go through the various steps towards electronic medical device reporting. A plan should be developed to transfer your company’s reporting procedures to be eMDR complaint. Failure to comply with FDA’s final rule could result in seizure of goods or products, citation (A formal warning of intent to prosecute), injunction (stops a company from continuing to manufacture, package or distribute products) (9), monetary penalties, and criminal prosecution (7). There are just over 4 months remaining to implement eMDR procedures, and this includes obtaining the necessary accounts, certificates, and becoming familiar with the complex systems and software that need to be utilized for eMDRs. Boston Biomedical Associates is available to offer assistance with these processes to enable your company to meet the compliance deadline of August 13, 2015. The clock is
counting down, act now before time runs out.
Figure 1 (10): This figure demonstrates the process for communication between the device manufacturer and the FDA. 1) The manufacturer fills out Form 3500A for an adverse event. 2) The form is submitted to the ESG and is transmitted
- Food and Drug Administration. Medical Device Reporting: Electronic Submission Requirements. Federal Register. [Online] February 14, 2014. https://www.federalregister.gov/articles/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirements.
- U.S. Department of Health and Human Services. Questions and Answers about eMDR – Electronic Medical Device Reporting. Guidance for Industry, User Facilities and FDA Staff. [Online] February 14, 2014. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM179471.pdf.
- U.S. Food and Drug Administration. Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities. FDA Medical Devices. [Online] January 13, 2015. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm2005737.htm.
- —. eMDR – Electronic Medical Device Reporting. FDA Medical Devices. [Online] March 17, 2015. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR%E2%80%93ElectronicMedicalDeviceReporting/default.htm.
- —. Health Level Seven (HL7) Individual Case Safety Reporting. FDA Medical Devices. [Online] June 26, 2014. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/eMDR–ElectronicMedicalDeviceReporting/ucm127948.htm.
- —. ESG Chapter 4 FDA ESG Web Interface Electronic Submissions. Electronic Submissions Gateway. [Online] January 26, 2015. http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm334449.htm#4_5.
- —. Letters of Non-Repudiation Agreement. FDA. [Online] March 11, 2015. http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm113964.htm.
- —. ESG Appendix C: Digital Certificates. FDA Medical Devices. [Online] July 31, 2014. http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm334781.htm#4.
- U.S. Department of Health and Human Services. Medical Device Reporting for Manufacturers. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM359566.pdf [Online] July 9, 2013. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
- AssurX. Electronic Medical Device Reporting (eMDR) . http://www.assurx.com/software-solutions/emdr-software.htm