At ComplianceQuest, we recently published a whitepaper on what would be the most efficient way to submit MedWatch information (reports of adverse events) to the FDA.
This whitepaper was presented as a conversation between a VP of Quality & Regulatory Affairs at a medical device company and the head of IT at the same firm. They explored the various options in front of them to submit e-MDRs or electronic versions (XML files) of MedWatch information (reports of adverse events) to the FDA.
It became an ongoing challenge, especially because one of the company’s products, a consumer-facing one, was seeing high-volume of reported complaints and therefore required at least 3000 eMDRs to be reported every month.
MedWatch is the FDA program that collects adverse events data coming from healthcare professionals and consumers. To comply with the FDA, medical device companies must report these complaints and adverse events by submitting an e-MDR. The FDA no longer accepts paper or emailed pdf reports. Medical device manufacturers and importers are required to submit MDRs to the FDA in an electronic format that the FDA can process, review, and analyze.
Currently, there are two ways for medical device companies to submit e-MDRs to the FDA’s electronic submissions gateway (ESG);
- FDA ESG WebTrader Interface through a web browser
- FDA ESG AS2 Gateway-to-Gateway or system-to-system
In the case of WebTrader, the process is manual and files are submitted via the app. In the case of the latter, the enterprise needs an AS2 submission system. The system must generate an HL-7 XML file and this process is automated.
Ideal Solution for Companies with a Large Number of Customers
One of our customers, the world leader in blood glucose monitoring systems, uses ComplianceQuest to automate and streamline all quality and compliance processes. The company serves over 20 million customers who rely on one of the devices manufactured by this company to manage their diabetes.
The company implemented CQ to automate the process of complaint handling, including triage and investigation workflows. (Incidentally, our RCA 5Why Whiteboard was one of the company’s favourite features during the demo!)
Considering one of their products serves millions of customers, the company’s quality team realized that using WebTrader for adverse event reporting was extremely inefficient.
Replacing WebTrader with a Single-Click Solution
Here are the steps that a customer (that uses a modern EQMS like ComplianceQuest) would have to go through – to submit an e-MDR using WebTrader:
- Download e-MDR file from EQMS (CQ Complaints Module, for instance)
- Launch the browser and sign in to WebTrader
- Upload e-MDR file to WebTrader
- Submit the file to FDA
- Download received ACKs from WebTrader
- Upload ACKs to Submission Record
Using WebTrader is inefficient and manual, and presented the following disadvantages:
- Manually move files to and from the tool, which is labor-intensive
- Too time-consuming for large companies
- Can lead to compliance issues
They were looking for a simpler way. What if the six steps above could be replaced with a single-click? With CQ’s MDR e-Gateway, clients can submit their MedWatch reports with the click of a button and automatically get updates on the status of their submissions.
It delivers the following value proposition to medical device companies:
- Speed to Compliance: Save time and labor related to e-MDR
- Real-Time Updates: Notifications keep customers updated
- Scalable: With a transactional subscription payment model
- Less Errors: Thanks to automatic file generation
- Cost Saving: No need for complex IT systems or IT support
- Visibility: Submissions records give an overview of MDR submissions
Additionally, complaint reports that are prepared within the ComplianceQuest EQMS can be submitted automatically (once a day, at a time specified by the customer). Users also have the option to submit individual reports immediately. Customers automatically receive important acknowledgements generated by the FDA after they submit their report, and the relevant documents are also automatically generated.
The e-MDR Gateway also comes with reports and dashboards so that the regulatory teams can keep track of all their submissions and get key insights into their performance.
To request for a demo of CQ’s e-MDR Gateway, request a demo here: