U.S. FDA Electronic Medical Device Reporting (eMDR)

Regulatory Oversight of the FDA

Medical device manufacturers and initial importers selling products in the United States must comply with post-market reporting requirements overseen by the U.S. Food and Drug Administration (FDA). These regulations ensure that the FDA can monitor the safety and effectiveness of medical devices, including IVDs, once they are available on the U.S. market. Under FDA Regulation 21 CFR Part 803, entities are legally obligated to submit certain post-market adverse events electronically for review.

Mandatory Reporting Requirements under 21 CFR Part 803

The eMDR regulation specifies the types of data and reports that must be included in every electronic submission. Any complaint involving a potential device failure under Part 803 must be promptly reviewed, evaluated, and investigated by a designated individual. These records must be maintained in a separate portion of the complaint file to satisfy regulatory standards.

Criteria for Reporting Adverse Events to the FDA

It is critical for manufacturers to correctly report adverse events, as failure to do so can lead to criminal sentences or financial penalties. An adverse event refers to any unfavorable occurrence involving a medical device in the market. Notification to the FDA is required if a device has:

• Caused or contributed to a death or serious injury.
• Malfunctioned and would potentially cause or contribute to a death or serious injury if the malfunction were to recur.

Submission Through the Electronic Submission Gateway (ESG)

The FDA requires that these reports be submitted electronically through the Electronic Submission Gateway (ESG) using the NextGen system. This electronic portal facilitates the efficient transfer of safety data from the manufacturer or importer directly to the agency for monitoring and analysis.

Timelines for eMDR Submissions

The time frames for reporting adverse events to the FDA vary depending on the severity and nature of the incident.

• Standard Reporting: If a device caused or contributed to a death or serious injury, an eMDR must be submitted to the FDA within 30 calendar days.
• Remedial Action Reporting: The FDA requires that adverse events be reported within 5 working days if remedial action is needed to prevent an unreasonable risk of substantial harm to public health.

Proregulations' U.S. FDA eMDR Reporting Services

Our team assists hundreds of medical device companies with post-market surveillance and adverse event reporting through specialized service modules.

• FDA ESG NextGen account setup and registration support
  We assist in establishing your FDA ESG NextGen account and help navigate the complex technical and administrative requirements for initial registration.
• Ongoing eMDR submission management
  Our experts prepare and submit adverse event reports on your behalf, managing the entire submission process through the FDA's ESG NextGen portal.
• U.S. Agent representation and liaison services
  For non-U.S. manufacturers, we act as your official U.S. Agent for all FDA communications related to adverse event reporting and vigilance.
• Regulatory monitoring and procedure alignment
  Our in-depth knowledge of FDA medical device regulations helps keep your vigilance procedures up to date and ensures compliance with 21 CFR Part 803.
• Complaint file and investigation support
  We provide guidance on navigating complex technical and administrative requirements for investigating complaints and maintaining compliant records.
• Post-market reporting and communication management
  We manage all vigilance-related communications with the FDA to ensure that your reports are completed accurately and on time.

If you are interested in our U.S. FDA eMDR reporting services and wish to ensure your compliance with 21 CFR Part 803, please feel free to contact us.