Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions
A few months back, we hosted a webinar on the eMDR Countdown to Compliance during which we learned that from beginning to end, the transition to electronic medical device report submissions (electronic MedWatch or FDA Form 3500A reporting) can take between four to six months. But how do you really know that you’re ready to comply with the new mandate?
Today, let’s point the microscope at one piece of the puzzle: testing your electronic medical device report submissions with the FDA’s CDRH. Testing gives you the opportunity to identify and correct trouble areas before you transition to production electronic reporting.
In case you missed it, you may download and view the recording on-demand here:
You can also find more on this process and other eMDR topics and tips in our complimentary e-book, available at the end of this post.
Why must you test before submitting MedWatch reports electronically?
You want to be sure you will be capable of meeting your reporting due dates electronically before the mandatory deadline on August 14, 2015. If there are issues, you want to resolve them now before making these steps part of your standard operating procedures. Once in production, reporting errors or file submission troubles can cause chaos — that is, failure to meet these mandatory reporting regulations can result in warning letters, fines, recalls, litigation, and even potential shutdown. Testing your process with the CDRH eMDR team ensures you’re ready to go into production with a proven electronic process.
Who needs to do this?
All medical device manufacturers and importers need to complete this process and go through a testing phase with the FDA’s Center for Devices and Radiological Health (CDRH) before you can transition to electronic reporting in a production environment. Whether you decide to use a B2B tool to submit your eMDR files, or you use the free FDA tools, you will want to go through this process. Your organization should either be using WebTrader or its hosted counterpart Web Trader Hosted Solutions (WTHS) as its primary or its secondary back-up process in case of unforeseen issues, such as a server error.
Even if you use a B2B tool to submit, have a back-up plan.
Specifically, you will need to have a well-tested method for submitting through either the FDA’s free tools, WebTrader orWTHS, both of which are free tools from the FDA available for download.
By B2B, we mean a high-volume HL7 ICSR Business-to-Business information interchange AS2 (Applicability Standard 2 security specification). This is typically an in-house solution or an option available from a third party; it’s also known as an EDI solution.
Where do you start?
To get to this testing phase, you will have already decided on your method for creating your eMDR files. For the purpose of this topic, we are really only focusing on testing your environment, connectivity, and successful submission of your electronic medical device report files:
Connect with the FDA
Regardless of the approach you choose, in order to leverage these free tools from the FDA all WebTrader and WTHS submitters must first request a test environment account with the FDA’s electronic submission’s gateway (ESG). Once your test account is established, you will also need to install and set up your chosen submission application. Lastly, be sure to test the connectivity between your application and the FDA.
- Request a test environment account with the FDA’s electronic submission gateway.
- Install and set up your selected submission application.
- Test your application’s connectivity with the FDA.
Verify your success
Now that your account is established and you know your connectivity with the FDA is working, it’s time to test that your electronic report submission has been successfully submitted to and received by CDRH. You will want to begin by reaching out to the CDRH’s eMDR team. Coordinate with them to begin your testing phase.
- Use real world data. Use data from past MedWatch reports to build your test reports, but do not submit with duplicate report numbers. Populate fields with real data to be sure field data passes through to the FDA as planned.
- Test every registration number. As part of marketing your medical devices, you registered your devices and establishment with the FDA. Test that all of these registration numbers correctly make it into the CDRH’s database from your eMDR files. You do not want to find out after go-live that one of your products’ registration numbers causes an error and its MedWatch data does not load properly into the database.
- Prepare and submit an XML file and your human-readable file. Then wait for the FDA eMDR project team to verify whether the information was entered into the MAUDE database correctly.
- Use the actual computer and the environment that your organization plans to use to submit your eMDR files. Remember you need to keep your tests as true to real-world circumstances as possible, and using the same computer will assist your team with pinpointing any potential trouble areas to address before going live.
More Tips & Tricks
The final deadline, August 14, 2015, is quickly approaching. Are you ready to submit your electronic medical device report files electronically? If not, take advantage of the coming months to educate and prepare your team, and give yourself time to get through the necessary testing phases.
Has your organization already successfully implemented eMDR? Your tips, advice, or lessons learned are welcomed in the comments below. Likewise, if your organization needs assistance with eMDR, Pilgrim is here to help.
Courtesy of Pilgrim Quality Solutions
Want to learn more about eMDR including this eMDR/CDRH testing process? Download our complimentary e-book.
- The eMDR Final Rule, which amends 21 CFR Part 803, can be found in 79 FR DOC 2014-03279, February 14, 2014.
- FDA Electronic Submissions Gateway (ESG)
- Health Level Seven (HL7) Individual Case Safety Reporting
- Web Trader
- WebTrader Hosted Solution (WTHS)