EMERGO SUMMARY OF KEY POINTS:

• The US FDA is rolling out a new series of updates to its electronic medical device reporting (eMDR) system for adverse events.
• Updates to the eMDR system have already begun, and will continue through October 2017.
• Changes to eMDR submissions pertain to UDI, combination products, formatting and problem code data.

The US Food and Drug Administration has begun rolling out updates to its electronic Medical Device Reporting (eMDR) system that will continue through summer and fall 2017.

These changes, which include Unique Device Identification (UDI) and formatting requirements, will be included on the agency’s eMDR System Enhancements web page. Through the eMDR system, US medical device market registrants are required to notify the FDA of adverse events involving their products using a web-based portal called the Electronic Submissions Gateway, or ESG.

What’s being updated for eMDR submissions?

Some eMDR updates have already gone into effect, while others will go live over the course of the next few months. Some of these updates include:

• UDI update: Submitters now should only include the DI portion of their UDI in the D4 field of a report unless the DI of a device is unknown; in such cases, submitters should enter the full UDI in this field. This update is already in effect.
• Acceptance of new XML formats: Older submission formats will be phased out over one year. This update will take effect June 29, 2017.
• Combination product field: eMDR submission forms will allow more room to include drug information for combination products involved in adverse events. This change will go live on June 29, 2017.
• Device problem codes: FDA Device Problem Codes used for eMDR submissions will be harmonized with Annex A of the International Medical Device Regulators Forum’s Adverse Event Reporting terminology document. Existing FDA problem codes will be accepted in electronic submissions through December 2017. Updates take effect July 7, 2017.

FDA medical device registrants should familiarize themselves with these and other updates to the eMDR system to ensure ongoing compliance with submission requirements.

Learn more about FDA eMDR requirements:

• FDA eMDR adverse event reporting support
• US FDA Unique Device Identification (UDI) consulting services
• Whitepaper: Implementing a post-market surveillance program