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FDA Delays eMDR System Adverse Event Codes Update

The electronic medical device reporting system adverse event code update was originally planned for deployment in April, but was delayed until July 5, 2018, to give industry more time to comply.

The US Food and Drug Administration (FDA) has delayed and rescheduled production deployment of the electronic medical device reporting system (eMDR System) adverse event code update for high volume reporters that use their own custom software to report adverse events to FDA (AS2 Submitters) until July 5, 2018. The corresponding eSubmitter interface update, used for lower volume reporters, will also occur on July 5, 2018.

FDA’s delay of the eMDR System adverse event code update should come as welcome news for AS2 Submitters, who must maintain their own custom software solution for adverse event reporting when using the eMDR System. AS2 Submitters who have been working to implement (or who have yet to start implementing) FDA’s enhancements with their own custom software now have a little more time to develop and validate necessary changes to their adverse event complaint handling systems when using the eMDR System.

FDA had originally planned to deploy the eMDR System adverse event code update on April 6, 2018, but the agency announced the delay because industry needed more time to comply. Specifically, FDA has deployed six eMDR System updates since early 2017, not including the eMDR System adverse event code update. Two of these previous updates have a similar July 2018 deadline. Additionally, the eMDR System adverse event code update is meant to serve as one of several other planned eMDR System updates meant to harmonize “FDA’s adverse event codes accepted in sections F10 and H6 of the 3500A form with the International Medical Device Regulators Forum (IMDRF) code terminology.”[1] Specifically, FDA has been participating in the IMDRF Adverse Event Reporting working group, which “aims to improve and harmonize device adverse event coding among other participating regulatory agencies.”[2] More information on the working group can be found here. As the working group publishes new annexes with new adverse event code sets, FDA intends to update the corresponding FDA code sets to harmonize with the new IMDRF code sets and then update the eMDR System accordingly.

The current eMDR System is not configured to accept IMDRF codes. Notably, the eMDR System will not accept IMDRF codes after production deployment of the eMDR System adverse event code update set for July 2018. Instead, the eMDR System adverse event code update will “only affect the Device Problem Codes and Manufacturer Evaluation Codes, which correspond to IMDRF Annexes A through D.”[3] Future eMDR System adverse event code updates will harmonize the remaining FDA codes with the IMDRF codes. During this time, AS2 submitters will need to conduct a one-to-one mapping of the IMDRF codes to the FDA codes to ensure they are not using incorrect or retired FDA codes before these updates occur. Once production deployment to the eMDR System occurs, retired FDA codes will be rejected.

FDA intends to deploy further eMDR System updates as more codes are harmonized.

Further, FDA intends for the eMDR System to accept IMDRF codes once the working group has published an initial version of all IMDRF code sets, but this will not happen in the foreseeable future. We will continue to closely follow developments in this area.

On February 13, 2014, FDA published a final rule that requires device manufactures and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports to FDA in an electronic format. See Medical Device Reporting: Electronic Submission Requirements, 79 Fed. Reg. 8832 (Feb. 14, 2014).

[1] View the eMDR System Enhancements here.

[2] Read more about the MDR Adverse Event Codes and Code Types here.

[3] View the eMDR System Enhancements here.

Copyright © 2022 by Morgan, Lewis & Bockius LLP. All Rights Reserved.National Law Review, Volume VIII, Number 89

About this Author

Phoebe Mounts, Food and drug attorney, Morgan Lewis

Phoebe Mounts counsels companies developing drugs, biologics, medical devices, and human cell and tissue-based products on US Food and Drug Administration (FDA) regulations. Her scientific background enables her to assist clients with product approvals for emerging technologies, such as combination products and companion diagnostics, including counseling on regulatory pathway issues and developing preclinical and clinical studies. Phoebe prepares submissions to the FDA, including applications for orphan-drug designation, humanitarian device exemptions (HDEs),...

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