Bernard Jee, Product Manager, Pilgrim Quality Solutions, an IQVIA company
The U.S. Food and Drug Administration (FDA) announced, on June 8, 2017, that updates and changes are being made to its Electronic Submission Gateway (ESG) system for electronic medical device reporting (eMDR). If you are not subscribed to the FDA listserv, this information may not be readily available unless you visit the FDA Gateway website to see the full list of the planned updates.
In the interim, there are key updates that will impact various components of the submissions process.
Don’t underestimate the value of new technology.
What may feel like an innocuous change, actually reflects that the FDA is keeping abreast with technological advancements and preparing to embrace new technology to better serve us all. The update of the HL7 ICSR XML format to R2 will allow the agency more capabilities in the future to enable manufacturers to submit a single report on multiple patients and multiple devices.
Currently, the FDA is accepting both R1 and R2 formats, but for the time being, it is only accepting one device and one patient in each report. The FDA has given a 1 year grace period for submitters to make updates to their system and will continue to accept R1 format of the HL7 ICSR XML until June 30th, 2018.
With the update to the R2 format of HL7 ICSR XML, the FDA has expanded the eMDR schema to include sections C and G of the 3500A form, which allows up to 20 drugs within a device-led combination product adverse event report to be submitted. This was not possible with the R1 format. This shows the progress of the eMDR system capabilities from its initial release, and one can only hope for more exciting updates from FDA. This also means more data will be provided to the FDA, and more data will be available for the FDA to analyze.
Take time to thoroughly review fields and files.
Other notable updates appear in the 3500A form itself, including the addition of an Ethnicity/Race field in section A5. Although this field has been added to the form, the FDA is not requiring this information for eMDR submission; however, it must be included by AS2 submitters using the FDA Electronic Submission Gateway. An additional system-related update is the addition of Environment and Submission Type elements to the Ack3 files, the acknowledgment that a submission was successfully received.
Updated Device Problem Codes are also available to be downloaded from the FDA website, and revised guidance on UDI field D4 was also announced in the June 8th, 2017 notice.
Consider your QMS as an essential eMDR support resource.
To ensure you are prepared for the upcoming submission process changes, here some helpful tips:
- If your QMS vendor provides automated submission from your Quality Management System (QMS) to the FDA Gateway, make sure that the XML files are updated to the R2 format.
- If you perform a manual submission via WebTrader using the XML file generated from your QMS, make sure that it is in the new R2 format.
- If you manually submit an entry in WebTrader, make sure that you are using the latest WebTrader client.
- Consider a QMS that performs automated submissions, such as Pilgrim Quality Solutions, enabling you to be more efficient and compliant.
Pilgrim SmartSolve® Complaint Management, helps manufacturers understand reporting requirements throughout the global marketplace. The system streamlines submissions with standard reporting for the FDA, EU, Health Canada, Japan, and Australia. It also enables users within global enterprises to easily configure decision trees or add regulatory reports for any country in the world. For medical device manufacturers and importers submitting eMDRs in the United States, Complaint Management automatically creates, validates, and formats the XML file for submission to the FDA. To further streamline compliance, when implementing in the Pilgrim Cloud QMS, Complaint Management automatically submits the eMDR file and receives and attaches the appropriate acknowledgement files (ACKs) from the FDA.
Stay on top of current and future updates. It’s a win-win.
The FDA is continuously performing maintenance on the ESG Gateway. Don’t be caught off guard. Make sure you subscribe to the FDA listserv to be advised when the ESG Gateway will be down so you can plan your submission(s) accordingly. Maintenance notices may also signify that perhaps new functions and features are being made available to enhance the process for submitters and to ensure Gateway reliability.
Don’t ignore the latest updates, and don’t be overwhelmed by them. And remember, there’s no need to walk alone on your Quality and Compliance journey — have your QMS provider alongside you when updates happen. Together, you’ll discover that FDA updates provide device and combination product manufacturers with a win-win scenario.
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