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FDA eMDR Adverse Event Reporting

Medical device manufacturers selling products in the United States must comply with postmarket reporting requirements outlined by the US Food and Drug Administration (FDA) and submit adverse events electronically to the FDA for review.

It is important to correctly report adverse events in the US, as failure to do could lead to severe financial penalties or even criminal sentences.

Properly submitting eMDRs to the FDA

If an adverse event occurs in the United States, Emergo can assist you in submitting an Electronic Medical Device Report (eMDR) to the FDA using their web-based Electronic Submissions Gateway (ESG).

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. After submission, your eMDR will be processed, reviewed and archived by the FDA Center for Devices and Radiological Health (CDRH).

Appointing an Account Holder for eMDR submissions

While you may submit eMDRs directly to the FDA, many manufacturers benefit from appointing an Account Holder to submit eMDRs on their behalf. Your appointed Account Holder ensures that eMDRs include necessary data required by the FDA and can provide additional postmarket surveillance support.

Choose Emergo to assist with EMDR reporting

Emergo has assisted hundreds of medical device companies with postmarket surveillance in the US. Here’s how we can help:

  • Emergo can help you to set up your personal account with the FDA’s Electronic Submissions Gateway so that you are able to properly submit eMDRs.
  • If appointed as your Account Holder, Emergo will submit eMDRs on your behalf and provide ongoing postmarket surveillance support.
  • Our experienced US consulting team will help to determine when incidents are reportable and ensure that all eMDRs are submitted correctly and on time.
  • Our in-depth knowledge of FDA medical device regulations ensures that your vigilance procedures will always be up-to-date.

Please contact us for more information on our medical device reporting services in the United States.

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Frequently Asked Questions

What are the timelines for medical device reporting in the US?

If your medical device caused or contributed to a death or serious injury, an eMDR must be submitted to the FDA within 30 calendar days. However, the FDA requires that adverse events be reported within five days if remedial action is needed to prevent an unreasonable risk of substantial harm to public health.

The FDA has issued an eMDR draft guidance that includes a full list of reporting timelines for various adverse events.

Am I required to submit medical device reports electronically?

Yes. The FDA has issued a final rule on Electronic Medical Device Reporting (eMDR) that requires manufacturers and importers to submit medical device reports to the FDA electronically starting in August 2015.