In February of 2014 the Food and Drug Administration (FDA) published the final rule that all major importers as well as foreign and domestic manufacturers of medical devices must submit their medical device reports or MDRs to the agency via electronic means (eMDR). The start date for electronic submissions is 13th August 2015.
After the 13th August 2015 start date of eMDR all applicable organizations will need to file electronically through one of two different methods so that the FDA will be able to store, review and eventually save these applications.
The two systems used are FDA eSubmitter and Health Level Seven (HL7) Individual Case Safety Report (ICSR). Here’s some additional information on these systems.
Understanding the eSubmitter
The FDA offers eSubmitter as an app that is free to download by those in the regulated industries. When using eSubmitter you are required to submit one medical device report at a time. In other words, you cannot submit batch claims through this application.
Typically companies will use this system for a very small amount of claims. Larger claim amounts will typically be done through another system. In order to process your claim you will need to fill out a MedWatch form that has become the FDA standard for processing claims.
Any claims you submit must be processed through the website gateway or CD. Neither printed nor locally stored medical device reports will be considered. Find out more about the eSubmitter by clicking here.
Health Level 7 Individual Case Safety Reporting
Using the HL7 ICSR system is typically reserved for batch applications that need to be uploaded using XML files. If your company has a large amount of medical device adverse events that need processing, organize them on your systems and upload them directly through this site. This will save a great deal of time when compared to submitting individual claims through eSubmitter.
Find the current Health Level 7 Individual Case Safety Reports implementation package by clicking here.
How to File—eSubmitter or HL7 ICSR?
In order to receive electronic records, the FDA Electronic Submissions Gateway (ESG) is used. This platform is used to process all electronic claims filed with the FDA.
To gain access to this platform you must first request a Web Trader Account. This account will be linked to your company and allow you access to the FDA servers for uploads and submissions.
Once your account is created you will submit test data. If your test passes guidelines, you will be assigned a production account for submitting your MDR information.
Benefits of Using Compliance Experts in GxP-Regulated Industries
While it is possible to submit claims on your own when dealing with the FDA there can often be a great deal of bureaucracy. This can result in import or approval delays which can cost your company a great deal of time, money and market share.
Since both electronic systems are new, medical device manufacturers often engage the help of compliance consultants to better understand these new requirements. Using expert guidance can also help avoid receiving a Form 483, or indeed a Warning Letter from the FDA.
GxP-CC has a proven track record in providing those in the field of Life Sciences with expert guidance in complying with regulations and requirements.