Medical Device Quality Series: Reporting Adverse Events to the FDA with Ease – A CQ Guide

In one of our earlier CQ Guides, we spoke about the importance of garnering insights from complaints data to improve quality metrics in the medical device industry. In this post – as part of our Medical Device Quality series – we’ll talk about streamlining the process of reporting adverse events to the FDA, especially in scenarios where the no. of e-MDRs that get submitted is fairly high.

e-MDR Submissions: Too Time Consuming?

Roger is the Vice President of Quality & Regulatory Affairs (QA/RA) at an exciting medical device company. He manages a wonderful team of regulatory, quality and compliance professionals to ensure each of the company’s products, services and internal processes comply with all relevant laws, regulations and standards.

But currently, he is grappling with a major challenge – one that is taking up a lot of his time.

He needs to figure out a better way to submit e-MDRs or electronic versions (XML files) of MedWatch information (reports of adverse events) to the FDA.

He didn’t have this issue with the company’s first product, because the number of eMDR submissions was less than 50 per month. Now, the company’s second product is a consumer-based device which is waiting for final FDA approval and the quality leaders expects the volume of eMDRs to be submitted anywhere between 3000 to 8000 every month.

It is a process that is cumbersome, inefficient and resource expensive. The quality leader – after consulting with his compliance team and other quality analysts – decides to evaluate alternatives and collaborates with the IT team to come up with a solution.

The Need: Modern, Efficient Solution to submit e-MDRs

Both the quality leaders as well the head of IT realize the importance of collaborating with each other to a simple way to submit e-MDRs.

Roger – the quality leader – starts with the fundamentals, just to make sure his IT team understands the importance of this.

What is an e-MDR?

It refers to electronic-Medical Device Report. It consists of sending electronic versions of MedWatch information (reports of adverse events) to the FDA. MedWatch is the FDA program that collects adverse events data coming from healthcare professionals and consumers.

Why are e-MDR submissions important?

Since August 2015, 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.

Typically, a U.S. based medical device company submits anywhere between 50 to 10,000 MDRs a month depending on the types of products it manufactures and the volume that is sold. The process is both time-consuming and labor-intensive.

Moreover, regulatory bodies in other countries are expanding to allow e-MDR submissions as well such as EU MIR reporting into the Eudamed database.

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

Option #1: Submit e-MDRs through the FDA ESG WebTrader Interface application. In this case, the process is manual and files are submitted via the app.

Option #2: Submit e-MDRs through FDA ESG AS2 Gateway into the FDA ESG database. This requires an Applicability Statement 2 submission system. The system must generate an HL-7 XML file and this process is automated.

Of course, there are challenges with both options.

Challenges with using WebTrader

Here are the steps that a customer (that uses a modern EQMS like ComplianceQuest) would have to take in order to submit an e-MDR using WebTrader.

Step 1: Download e-MDR file from EQMS (CQ Complaints Module, for instance)
Step 2: Launch browser and sign in to WebTrader
Step 3: Upload e-MDR file to WebTrader
Step 4: Submit file to FDA
Step 5: Download received ACKs from WebTrader
Step 6: Upload ACKs to Submission Record

Now, with the right solution, all these steps can be replaced with the click of a button through the automated process of the MDR e-Gateway. But, more on that later.

Overall, using WebTrader is inefficient and manual. Specifically, these are the disadvantages:

Manually move files to and from the tool, which is labor-intensive
Too time-consuming for large companies
Can lead to compliance issues

Challenges with using Automated AS2

To put it simply, using Automated AS2 is costly and complicated. It’s difficult to build a submissions system for the following reasons:

Would have to develop or purchase a system
Could take >$200,000 over many months to build
Small to medium size companies do not have the IT bandwidth or expertise to build or manage it

What are customers doing today?

Enterprises are outsourcing the process of building the B2B solution and then they maintain it internally with their IT staff (this is expensive)
Use the free WebTrader (this is manual and inefficient)
Outsource to expensive e-MDR services in case of high volumes (this is not ideal because you are reliant on a third party)

They go deeper to document the pains and needs of both the regulatory and IT teams.

Need of the hour

Pain points for the Regulatory Team

Lack of real-time visibility into the performance of e-MDR submissions
Risk of non-compliance (filing error or late submission)
e-MDR submission is a labor-intensive task for the regulatory team

The Need: An efficient solution that reduces the need for more people, while also ensuring compliance. It must also be a solution that provides visibility to the regulatory and quality team.

Pain points for the IT Team

Internal team might not have the expertise to develop a B2B solution
High level of support needed for the internal system
Out-of-the-box solutions might be too expensive

The Need: A simple, cloud-based solution that reduces IT costs and the need for resources.

Overall, the requirement was clear. Both quality and IT leaders want an e-MDR submission solution that offers:

Automated and ideally single-click way to submit to the FDA
Had the ability to track the status of e-MDR submissions
Stay up to date with the progress of submissions
Minimizes risk of errors

ComplianceQuest’s MDR e-Gateway: The Ideal Solution

Let’s talk about some of the major advantages of CQ’s MDR e-Gateway:

Advantage #1:

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.

Key Benefits:

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

Advantage #2:

Complaint reports that are prepared within CQ are submitted automatically once a day at a time specified by the customer. Users also have the option to submit individual reports immediately.

Advantage #3:

Customers automatically receive important acknowledgements generated by the FDA after they submit their report, and the relevant documents are also automatically generated.

CQ’s gateway delivers the following acknowledgements:

Acknowledgement 1 (ACK1): Generates the Date/Time the eMDR is received
Acknowledgement 2 (ACK2): The CDRH received the MDR
Acknowledgement 3 (ACK3): Pass or Fail

Advantage #4:

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.

Reports Submissions: Customers can see the status of all their submitted reports in one place
Built-In Dashboards: To answer questions like: How many submissions per month? And, how many reports were delayed?

If you are looking for an easier and efficient way for e-MDR filing then look no further. ComplianceQuest’s MDR eGateway can be the perfect solution for you.

To know more, request for a demo here: https://www.compliancequest.com/online-demo

Everyone at Candelis uses ComplianceQuest to some extent. Whether it’s via remote access or in the office, we take care of all of our quality requirements through the platform.

I was excited about the things we could do to work faster and smarter. Everything is better organized and there are more customization options. The best thing you can hope for is a seamless upgrade, and that’s exactly what we experienced.

I am really impressed with the ComplianceQuest dashboard because I can customize it exactly the way I want and every employee can do the same.

- Larry Collie, Quality Systems Manager, Candelis Inc.