Electronic MDR Services
Save time by authorizing Qualomics to prepare and submit electronic medical device reports for you.
Our Process
Delegation
Establish Qualomics as your authorized account holder to submit eMDRs on your behalf.
Notify
When you identify an adverse event, you notify Qualomics and we prepare the form 3500 or 3500A.
Report
We submit the report to FDA using the required WebTrader portal.
Confirm
We provide you with the completed report and confirmation receipts.
Qualomics is setup with FDA to submit eMDRs on your behalf. We have current and active eSubmitter and WebTrader accounts ready to go.
What types of events must be reported?
FDA describes both voluntary and mandatory reporting rules in 21 CFR 803.
We can prepare and submit Form 3500 for voluntary reports or Form 3500A for mandatory reports.
Mandatory reporting is required:
- If any medical device has caused or contributed to a death or serious injury
- Malfunctions are likely to cause or contribute to death or serious injury if they recur.
Can someone submit an eMDR on my behalf?
While manufacturers can submit eMDRs directly to the FDA, many manufacturers choose to appoint an Account Holder to handle the submissions on their behalf. We are ready to submit immediately, while it can take your firm weeks to months to get an ESG account established.
We will provide you with a template Letter of Authorization that appoints Qualomics as your Account Holder with the authority to submit eMDRs on your behalf.
When appointed as your Account Holder, Qualomics will submit eMDRs on your behalf. We offer a simple monthly subscription that allows us to submit eMDRs as your Account Holder.
Qualomics provides the service of preparing FDA form 3500A for medical device reportable events. We serve as your Account Holder and submit eMDRs on your behalf.
Frequently Asked Questions
What is an adverse event?
An adverse event can refer to any unfavorable occurrence involving your medical device in the market. However, you must report it to the FDA if a medical device has: Caused or contributed to a death or serious injury Malfunctioned and could potentially cause or contribute to a death or serious injury if the malfunction were to recur FDA Regulation 21 CFR Part 803 specifies the types of reports and data that must be included in each eMDR submission. Once received, the FDA Center for Devices and Radiological Health (CDRH) will process, review, and publish your eMDR.
Do you need to submit a medical device report to FDA?
Medical device manufacturers must comply with adverse event reporting requirements set by the FDA by submitting the reports to the agency. Failure to do so can result in financial penalties and even criminal sentences. The FDA uses the reports to monitor the safety and performance of medical devices and take action if necessary to protect public health. It is important for manufacturers to have a good understanding of the reporting requirements and to have a process in place for timely and accurate reporting of reportable events. As of 2015, medical device manufacturers are required to submit adverse events electronically using FDA’s web-based Electronic Submissions Gateway (ESG) (aka WebTrader). Additionally, manufacturers must use the eSubmitted to prepare the FDA Form 3500A. Once submitted, the reports are available in the public MAUDE database.
Qualomics has an active account with WebTrader and eSubmitter and can submit your eMDR quickly.
What if I want to open a WebTrader account on my own?
To open a WebTrader account with the FDA’s Electronic Submissions Gateway, you will need to follow these steps:
What do I need to do to start submitting MDRs electronically to FDA?
- Request a Web Trader Account from the ESG.
- Submit a Letter of Non-Repudiation to FDA.
- Obtain a personal digital certificate.
- Submit test data.
Prepare a test eMDR (a mock report and not an actual adverse event report) containing the information specified in the appropriate section of 21 CFR Part 803: 803.32 for user facilities, 803.42 for importers, or 803.52 for manufacturers.
- Receive a production account from the ESG.
CDRH will notify ESG to provide you with the production account once you have completed successful testing.
- Use the production account to send your actual eMDRs to FDA.
Helpful resources
Current forms 3500 and 3500A: MedWatch Forms for FDA Safety Reporting | FDA
Outline of the process: User Guide | FDA
Checklist of the steps: Setting up a WebTrader Account Checklist | FDA
Step by step guide with screenshots: Microsoft Word – ESG Accounts Management Portal User Guide.docx (fda.gov)
