FDA eMDR Adverse Event Reporting for Medical Devices

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

ANSWERED ON THIS PAGE:

What is FDA eMDR reporting, and why is it required?
What are the updated FDA eMDR requirements, including ESG NextGen?
How can Emergo by UL help medical device companies comply with eMDR obligations?

What is FDA eMDR reporting, and why is it required?

Medical device manufacturers and initial importers selling medical devices, including in vitro diagnostics (IVDs), in the United States must comply with post-market reporting requirements outlined by the U.S. FDA and submit certain adverse event reports electronically through the Electronic Submission Gateway (ESG NextGen) system to the FDA for review. These reports help the FDA monitor the safety and effectiveness of medical devices on the U.S. market.

FDA medical device reporting requirements under 21 CFR Part 803

The FDA Regulation 21 CFR Part 803 specifies the types of reports and data that must be included in each eMDR submission. Any complaint involving the possible failure of a device under Part 803 must be promptly reviewed, evaluated and investigated by a designated individual and be maintained in a separate portion of the complaint.

What is an adverse event, and what is your obligation to report to the FDA?

It is critical to correctly report adverse events in the U.S., as failure to do so could lead to financial penalties or even criminal sentences.

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.

How can Emergo by UL assist with FDA eMDR reporting?

Emergo by UL experts help hundreds of medical device companies with post-market surveillance and adverse event reporting. Whether you are a domestic or international manufacturer, an importer, or a company needing U.S. Agent representation, we provide tailored services to fit your needs.

Here’s how we can help you:

FDA ESG NextGen account setup and registration support

Assistance establishing your FDA ESG NextGen account.
Navigating the complex technical and administrative requirements for initial registration.

Ongoing eMDR submission management

Preparing and submitting adverse event reports on your behalf.
Managing the submission process through FDA’s ESG Next Gen.

U.S. agent services

For non-U.S. manufacturers, we act as your U.S. agent for all FDA communications related to adverse event reporting.
Managing vigilance communications and post-market reporting.

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

What are the timelines for medical device reporting in the U.S.?: 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 working days if remedial action is needed to prevent an unreasonable risk of substantial harm to public health or for events which the manufacturer has received a written request from FDA.
Am I required to submit medical device reports electronically?: Yes, manufacturers and importers are required to electronically submit eMDRs to the FDA. Additionally, with the implementation of ESG NextGen, electronic submissions must now comply with updated technical and security requirements established by the FDA to improve the submission process.