Medical Device Reporting Services

Save time by authorizing Qualomics to prepare

and submit electronic medical device reports for you.

Our Process

Delegate

Authorize Qualomics to submit eMDRs on your behalf.

Notify

Notify Qualomics when there is a reportable event.

Report

We prepare and submit the report to FDA for you.

Z

Confirm

We send you the records and receipts. 

Get started now

Your Journey to Easy FDA Compliance

Getting set up to submit medical device reports to the FDA can be a real headache. It’s a long, complicated process that takes up a lot of your time and resources.

That’s where Qualomics comes in. We’re ready to handle the whole process for you. Sit back and relax.

With Qualomics on your side, you don’t have to worry about the nitty-gritty details. Our team makes sure everything is done right and on time, so you can focus on what you do best—innovating.

Imagine the peace of mind knowing your mandatory reports are taken care of without the hassle. With Qualomics, the setup and submission process is smooth and straightforward. We’ve got your back every step of the way.

Take the First Step

Join the many who’ve already made their compliance process easier with Qualomics. Let us help you get started on your path to hassle-free FDA reporting today.

What types of events must be reported?

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.

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.

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. 

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 reportable event?

An reportable event can refer to any unfavorable occurrence involving your medical device in the market. However, mandatory reports are required by 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 I 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?

  1. Request a Web Trader Account from the ESG.
  2. Submit a Letter of Non-Repudiation to FDA.
  3. Obtain a personal digital certificate.
  4. Submit test data.
  5. 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.
  6. Receive a production account from the ESG. CDRH will notify ESG to provide you with the production account once you have completed successful testing.
  7. 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)

       

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