FDA eMDR Adverse Event Reporting for Medical Device Companies

Reporting adverse events to the FDA

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

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

How to report an adverse event 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).

Adverse event definition and your obligation to report to the FDA

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 archive your eMDR.

Appointing an account holder for FDA 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 can verify that your eMDRs include the necessary data required by the FDA, and can provide additional post-market surveillance support. To appoint an account holder, submit a Letter of Authorization to the FDA naming the company who will submit eMDRs on your behalf.

Choose Emergo to assist with FDA medical device eMDR reporting

Emergo helps hundreds of medical device companies with post-market surveillance and adverse event reporting in the US. Here’s how we can help you:

• Emergo can provide guidance as you set up your personal WebTrader 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 post-market surveillance support.
• Our experienced US consulting team can help you determine when incidents are reportable and ensure the eMDR information is properly completed.

Our in-depth knowledge of FDA medical device regulations helps keep your vigilance procedures up-to-date. Emergo can help you navigate adverse event reporting in the US.

Common questions regarding FDA eMDR adverse event reporting

What are the timelines for medical device reporting in the US?
The time frames to report adverse events to the FDA vary depending on the severity of the incident. If your 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.

Am I required to submit medical device reports electronically?
Yes. As of August 2015, manufacturers and importers are required to electronically submit medical device reports (eMDRs) to the FDA.

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.