Complaints  >  FDA eMDR - Electronic Medical Device Reporting

FDA eMDR - Electronic Medical Device Reporting

FDA eMDR -FDA Electronic Medical Device Reporting
FDA eMDR -FDA Electronic Medical Device Reporting

Being a regulatory body for medical devices, the FDA gets thousands of adverse events reports. To get a better handle on the reports, they needed a system that would help collect, review, and analyze this information. To that end, the FDA introduced an electronic medical device reporting system that allows medical device manufacturers and importers to file adverse medical device events reports electronically.

What is FDA Electronic Medical Device Reporting (FDA eMDR)?

The FDA established the MedWatch information program in 1993 to help collect data on adverse events from consumers and healthcare professionals. FDA eMDR refers to an electronic-Medical Device Report consisting of electronic versions of the MedWatch form, also known as Form FDA 3500A, to be submitted to the FDA. Medical device companies must fill out the appropriate MedWatch forms with different categories of information in case of an adverse event before submitting.

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Latest Approach in FDA eMDR

Center for Devices and Radiological Health and FDA launched eMDR with proper guidance to simplify the procedure of submitting medical device adverse event reports. FDA has resorted to paper-based reporting for a longest time and has received Medical Device Reporting (MDR) via mail. However, with the advent of technology, FDA is forging ahead and revamping its post-market surveillance tools to become electronic. EMDR is now used to identify possible device-related safety issues, track device performance, and contribute to the benefit-risk assessment of the devices. To submit eMDR, FDA launched Electronic Submissions Gateway (ESG).

FDA Electronic Submissions Gateway (ESG)

The Electronic Submissions Gateway (ESG) has various reports and dashboard features that can be used to track and review submissions and performance. The FDA ESG is a secure central entry point for all electronic eSubmitter and HL7 reporting to the FDA. eMDR uses ESG as it is an FDA-approved solution for electronic submissions.

FDA eMDR latest approach
FDA eMDR submitting procedure

Procedure for Submitting FDA eMDR

According to the guidance, FDA suggests two possible ways to submit the reports based on the frequency of reporting, including

  • eSubmitter software, a tool developed by the CDRH for low-volume reporting
  • the Health Level Seven (HL7) Individual Case Safety Report (ICSR) form for high-volume reporting using the XML files

The FDA eSubmitter software supports electronic submissions, and this software and all output files exist locally on your computer. This lets you work on a submission offline, save it, and continue later. The eSubmitter tool does not transmit any gathered information across the web to FDA, and FDA cannot assess, access, or augment the information on your local computer through this software. Each user must take responsibility for the security of the software and the data it contains.

HL7 (Health Level Seven) is a set of standards, formats, and definitions aimed at the development and advancement of clinical and administrative standards for healthcare. HL7 implements messaging standards for managing, exchanging, and integrating data that support clinical patient care, management, delivery, and assessment of healthcare services.

Electronic Medical Device Reporting Process Flow

To submit Medical Device Reporting electronically, set up a Web Trader Account and then submit it to process through the FDA ESG successfully. In the Electronic Medical Device Reporting process flow, you should consider the following steps:

  • You need a Web Trader interface application from the ESG15.
  • You should follow ESG instructions according to the guidance compliance submission.
  • You must submit guidance compliance submission and prepare a test eMDR.
  • After completing testing, you will receive a notification from the Center for Devices and Radiological Health (CDRH)
  • Then, you will receive a production account from the ESG to send your actual eMDRs to the FDA.

According to the guidance, the process for electronic submission via ESG is as follows:

  • After receiving an inbound submission, the ESG sends an MDN (Message Delivery Notification) or Receipt or Acknowledgment 1 to the submitter.
  • Then, the submission is automatically transferred to CDRH.
  • The ESG sends Acknowledgment 2 to indicate the submission reached CDRH.
  • CDRH verifies and processes the submission and sends Acknowledgment 3. This demonstrates that the submission is effectively uploaded into the Adverse Event database.
receive acknowledgement
final acknowledgement

After report submission, the user will receive three acknowledgments, including:

  • Acknowledgment 1:Message Disposition Notification (MDN) or Receipt acknowledgment demonstrating that the ESG received the eMDR.
  • Acknowledgment 2:This demonstrates that CDRH has received the eMDR.
  • Acknowledgment 3:This demonstrates the status of whether eMDR is passed or failed into CDRH’s adverse event database.

According to the FDA, medical device manufacturers can use this process to simplify and accelerate all the regulatory procedures associated with medical device adverse event reporting.

Medical Device Reporting

Medical Device Reporting Just One Click Away with CQ’s e-MDR Gateway

How is the Electronic Medical Device Reporting System Beneficial?

Medical device manufacturers can easily and efficiently submit eMDRs to the FDA gateway by automating the quality process of a medical device in compliance with FDA quality and compliance standards. Electronic Medical Device Reporting System enables users to submit reports directly to the FDA’s system automatically. You can reduce submission errors by connecting the submission process directly to the complaint handling software and corrective action.

FDA eMDR - Electronic Medical Device Reporting Benefits
  • Improved Collaboration

    Electronic MDR (eMDR) can enhance collaboration within an organization. EMDR facilitates better communication with the FDA and removes “crossover emails” by using acknowledgments and an immediate receipt. FDA helps submit adverse events seamlessly and maximize the FDA response to those events.

  • Reduced Cost

    eMDR can also help reduce costs through automation as it helps reduce the need for administrative overheads and traditional modes of communication. Companies can directly upload adverse events with a single click to the FDA.

  • Retaining Record

    Submitting reports in a paper format involves backlogs and delays in entering the information into the database, which is a significant challenge. With the help of eMDR submission, you can retrieve old records with a single click, as everything is stored in a data repository. eMDR ensures that all essential documents are readily available. Combining with acknowledgment of the original submission helps avoid confusion over matching receipts, acknowledgments, or events for each submission.

  • Quicker Report Submission

    eMDR provides a collaborative environment between the organization and FDA to flag submission errors quickly and proactively review and correct those errors by responding to questions. This can help to reduce response time from the FDA significantly.

  • Retrieve Data quickly

    You can retrieve data quickly with the help of eMDR software, as all related files are centralized in one easily accessible and searchable location. Thus, users can quickly extract documentation.

  • Secure Environment for All Adverse Events

    eMDR acts as a single point of entry to process all electronic submissions in a highly secure environment. Within a secure environment, organizations can store both internal compliance data and any FDA responses, and eMDR enables companies to reduce the wait time between submissions significantly. It also reduces the chance of human error.

  • Savings on Resources

    With the help of electronic forms, you can save resources as it requires less time to submit an online form than it does to transcribe electronic data onto paper and send it to FDA by mail.

  • Quick FDA Responses

    eMDRs accelerate FDA review time and analysis, having more efficient decision-making capability. As all medical device reports are now electronic, the FDA can access safety records easily and quickly. This ensures regulatory decisions are made using the most recent information.

If you are looking for an easier and more efficient way for e-MDR filing, then, ComplianceQuest’s MDR eGateway can be the perfect solution for you.

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how CQ helps companies with electronic medical device reporting

How ComplianceQuest Helps Companies with Electronic Medical Device Reporting (eMDR) Compliance?

Product manufacturers should report any adverse event or issue raised due to medical devices to the U.S. Food and Drug Administration (FDA). ComplianceQuest helps companies in Electronic Medical Device Reporting (MDR) compliance by providing a closed-loop automated reporting system for adverse event reporting without needing EDI systems or additional third-party tools.

ComplianceQuest’s electronic medical device reporting (eMDR) software solution simplifies and digitizes device manufacturers’ reporting processes and coordinates them with regulatory guidelines. ComplianceQuest’s eMDR automates electronic medical device reporting (eMDR) submission directly to the FDA gateway for MedWatch 3500A reports. CQ also enables full compliance with FDA CFR 21 Part 803 reporting guidelines to report adverse events related to death, serious injury, or device malfunctions for medical device manufacturers and device user facilities.

ComplianceQuest’s automated decision tree and regulatory reporting feature can help save time for both the regulatory affairs (RA) and quality teams in submitting a complaint to the FDA or any other regulatory authorities. With the help of CQ’s Complaint Management solution, you can get a fully integrated MDR eGateway that helps automate the process of submitting eMDRs to the FDA. It’s easy to submit an eMDR to the FDA with just one click and get updates on the status of the submissions. This also can help you to remove the complexity of handling various servers and IT infrastructure while sending reports and attachments and obtaining acknowledgments with the help of the FDA Electronic Submission Gateway (ESG).

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Our company has been using this CQ product for our QMS beginning with January 2018. I couldn’t be more pleased with the support we have received developing and rolling out the Complaint Management tool with both internal and external customers.Thanks Lee and Prashanth!

Brian Banerdt,
Global Director of QHSE


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Collect, review, analyze and handle adverse event reports with FDA eMDR

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Frequently Asked Questions

  • According to FDA 21 CFR part 803, all manufacturers and importers of marketed medical devices must submit FDA Form 3500A. eMDR is the same, in an electronic format that contains all the details that can be reviewed by FDA.

  • The FDA is not accepting paper or emailed pdf reports since August 2015. eMDR is essential here because it is vital to submit MDRs to the FDA in an electronic format for medical device manufacturers and importers so that the FDA can process, assess, and analyze them.

  • eMDR contains all the information as mandated by 21 CFR Part 803. eMDR includes medical device reports in an electronic format that FDA can use for process and review. The regulation has various subsections that can be referred to by multiple parties filing eMDR. While importers must include the information stated in 21 CFR 803.42, manufacturers can refer to 21 CFR 803.52 and users to 21 CFR 803.32.

  • #1 Clients can submit their MedWatch reports with one click with the help of CQ’s MDR e-Gateway, and automatically get updates on the status of the submission. Thus, you can

    • Save time and labor related to e-MDR

    • Get real-time updates

    • Get fewer errors with a transactional subscription payment model

    • Save costs due to no need for complex IT systems or IT support

    • Obtain an overview of MDR submissions through submissions records

    #2 CQ complaint reports have been submitted automatically once daily at a time specified by the customer. Users also can submit individual reports immediately.

    #3 Once customers submit their reports, they will automatically receive essential acknowledgments generated by the FDA, and the related documents are also automatically generated.

    #4 The e-MDR Gateway embeds dashboards and reports to keep track of all their submissions and get essential insights into their performance.

    • Reports Submissions: Customers can see the status of all their submitted reports in one place

    • Built-In Dashboards: This helps answer questions like how many monthly submissions and reports were delayed.

  • The FDA has published mandatory regulations under 21 CFR Part 803 for medical device reporting for manufacturers, importers, and user facilities. They are as follows:

    • Regulation for User Facilities: As per 21 CFR Part 803, a user facility should submit an electronic medical device report within ten days of a device having caused any severe injury or contributed to the death of a patient at the facility. When a user facility becomes aware of an adverse event, they must report the incident to the device manufacturer or the FDA instead.

    • Regulation for Device Importers: Under 21 CFR Part 803, a medical device importer must file via the electronic medical device reporting process within 30 days of a device that may have caused death or severe injury. The FDA specifies that the importer should learn about the adverse event from any source, whether from user facility reports, the affected individual, or even the media.

    • Regulation for Device Manufacturers: Medical device manufacturers must submit an electronic medical device report within 30 days of a device may have malfunctioned or contributed to a death or severe injury.

  • Using a decision tree capability, you can determine whether a medical device problem is a reportable event. CQ’s Quality Management System for manufacturing is embedded with a decision tree that supports identifying reportable hostile events using a flowchart-like structure.


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