Bernard Jee, Product Manager, Pilgrim Quality Solutions
Keeping on top of regulatory updates is an ongoing challenge. Regulatory bodies are constantly making updates and Life Sciences organizations are expected to interpret these guidelines and fold them into their existing quality and compliance systems. We’re all aware that the cost of misinterpreting or ignoring these updates is high. That’s why it’s important not only to monitor these updates, but also to closely examine them for unintended consequences to the rest of your quality and regulatory processes. In this post, we’ll examine a recent update to FDA electronic submissions and shine a light on some unintended consequences and potential missed communication from this update.
eMDR and UDI Submissions
Electronic Medical Device Reporting (eMDR) submissions and Global Unique Device Identification Database (GUDID) submissions are sent through the FDA’s Electronic Submissions Gateway (ESG). Regardless of the submission type, the ESG generates three Acknowledgements (ACKs) to confirm that the submissions have been routed to and/or received by the correct FDA systems.
eMDR and UDI submission methods may differ based on the volume of filings. Manufacturers who have a low volume of unique identifiers or adverse events to report will submit individual records through web interfaces provided by the FDA, such as WebTrader for eMDR.
High-volume submitters will likely take advantage of an automated gateway-to-gateway submission method that transmits multiple records using AS2 communication protocols. High-volume submitters using the AS2 Gateway will be affected by upcoming changes to FDA Acknowledgements – has your gateway provider ensured their system is compliant with both the current and future system specifications?
Are You Up-to-Date on Recent GUDID Changes?
Let’s examine some recent changes the FDA has made to the ESG ACK 3 schema. In February 2017, the FDA sent out a notification of this update to its Electronic Submission Gateway subscription list. The subject of the message was clearly identified as GUDID-related, however this message detailed a number of changes taking place within the system. Specifically, there will be an additional “Submission Type” added to the ACK 3 message to identify the submission as GUDID. There will also be an “environment” data element to identify whether the submission was sent to the GUDID production or test environment. However, a third critical element to this message is that the schema file for the ACK 3 message has also been updated.
It is critical to note that the impact of this change extends beyond UDI submissions. Even subscribers who monitor these notifications on a daily basis may have missed that the ACK 3 schema changes will affect eMDR as well, even though there was no specific reference to this impact in the FDA notice.
eMDR and UDI: Updating the ACK3 Schema
If you’re only performing eMDR submissions, you might think that the FDA’s recent update won’t affect your submissions process. That’s where closer inspection is needed. All submitters should be aware that the FDA is updating the schema for Acknowledgement (ACK) 3 as a part of this update. If you are submitting to the ESG via the FDA’s AS2 Gateway, there will be an impact to your system when the new ACK 3 schema is rolled out.
What Does This Mean for Your Submissions Process?
The new ACK3 format is currently deployed in the ESG test environment (pre-production deployment started at the end of March 2017) and is targeted to be rolled out to the FDA’s production environment in June 2017. This means that manufacturers who are currently submitting eMDRs using an AS2 system will need to update and test their ACK 3 schemas over the next several weeks to prepare for this change or risk a disruption in their ability to carry out compliant submissions.
Until the new schema goes into production, this update will create a unique challenge for any manufacturer that is just beginning to submit eMDRs through the ESG. The FDA only has one ESG “test system” and it currently does not match their “production system” – the “test system” is configured to accommodate the upcoming scheme changes. Manufacturers may have difficulties testing eMDR submissions and have to deal with PQ nonconformances until the new schema is rolled into production, so they should allow additional time for this in their deployment plans.
In either case, the time to prepare for the updated schema is now. Both new and existing submitters will need time to develop and test against the new schema. If you’re using an in-house or third-party AS2 system, be sure the updates you need to be ready have been tested. This will include obtaining the new ACK 3 schema, making the changes in your environment, and setting up an environment with the FDA to test the new format. This could also include having a ready-to-deploy co-existing system to ensure no interruption in the submission process once the FDA switches to the new schema in their production environment.
The Right Partner for eMDR
If you’re a Pilgrim Cloud customer, your system is ready for this upcoming update. The Pilgrim AS2 Gateway submission system will be ready when the FDA decides to switch to the new schema. Pilgrim has already developed and tested necessary solution updates. We’ve worked with the FDA to implement steps that will accommodate both the current and new ACK3 formats for our Pilgrim Cloud customers.
Pilgrim’s SmartSolve® Complaint Management solution automatically creates, validates, and formats the eMDR XML file for submission to the FDA. To further streamline compliance, when implementing in the Pilgrim Cloud, Complaint Management automatically submits the eMDR file and receives and attaches the appropriate ACKs from the FDA.
SmartSolve Complaint Management
SmartSolve Complaint Management provides a closed-loop mechanism to implement effective, timely resolutions to customer issues and adverse events.