Author: Suzanne Broussard, PhD  | November 9, 2020  

FDA’s recently finalized modifications to the electronic Medical Device Reporting (eMDR) system include the addition of new fields to harmonize with terminologies set by the International Medical Device Regulators Forum (IMDRF). These changes are designed to “improve transparency and analysis of the MDR data contained in the public Manufacturer and User Facility Device Experience (MAUDE) database” and are part of the FDA’s push for regulatory harmonization. 

Device manufacturers now have until February 28, 2021 to use IMDRF codes instead of the retired Patient Problem Codes and Device Component Codes. The original production deployment date of September 7, 2020 was extended to give manufacturers a little more time to adapt to the changes.  

Here is a summary of the updates to the eMDR system

• Includes new elements for Summary Report and NOE (Number of Events) based on FDA Form 3500A so that submitters will not need to report this information in B5 (Event Narrative) with precise text formatting  
• Addition of adverse event codes to harmonize with IMDRF Annex E, F, G Codes  
• FDA Adverse Event codes update that affect the Device Problem Codes and Manufacturer Evaluation Code 
• New options in the patient gender field 
• New elements or changes to Exemption Number reporting, indications to submission environments, and B5 and H1 (now mandatory) to reject options not reported properly 
• Enable a reporter to identify whether the report relates to a combination product 
• Combination product fields added to allow submitters to include information of up to 20 drugs within a device-led combination product adverse event report 

The current eMDR reflect FDA’s updates to Form 3500A, which is used by medical device manufacturers, importers, distributors, and user facilities to report diverse events and other system enhancements. 

FDA further aligned this reporting system by adding two fields from FDA Form 3500A to the public MAUDE database to provide additional information on related devices and the nature of adverse events. 

• Patient problem codes 
• Marketing submission number (for submissions such as 510(k) and PMA) 

To help manufacturers with a smooth transition to the newest eMDR format, the Center for Devices and Radiological health (CDRH) has created a downloadable file package to assist in implementing software for generating the HL-7ICSR XML for eDMR submissions. And updates on new and retired codes MDR Adverse Codes are easy to find. 

The updated eMDR is one of many changes being implemented by FDA. Indeed, 2020 has been an active year for FDA as they work to harmonize across systems.  

Here is a short list of posts with additional information on specific programs recently updated by FDA

• FDA Experts Provide Tips to Eliminate eCopy Holds for Premarket Submission Applications: FDA Touts eSTAR Development   

• FDA Finalized Two Guidance Documents for the Abbreviated 510(k) Safety and Performance Based Pathway: Use of Performance Measurements Instead of Direct Comparison Testing for Medical Devices 

• Nuances of Using the Safety and Performance Pathway for Submitting a 510(k) for Certain Device Types 

It takes a team of experts to implement all the regulatory documentations required to get and keep your medical device in compliance, especially ever changing and demanding US and European regulatory requirements.  

If your organization needs support establishing or updating technical documents for medical devices, Criterion Edge has a team of document experts ready to partner with you. Please reach out to us for a free consult.