Starting August 14, 2015, the FDA will require all medical device manufacturers to submit MDRs electronically. The FDA will no longer accept paper submissions from manufacturers as it has in the past.
If you’re a manufacturer that doesn’t already submit electronically, now is the time to start preparing to submit electronically. Below you’ll find some useful information to get started. Submitting reports electronically has many benefits over paper submissions including reducing the amount of data entry and expedited processing.
What you’ll need:
The eSubmitter Application or the HL7 ICSR standard to format reports
A Web Trader account from the Electronic Submissions Gateway
Manufacturers have two options for submitting reports electronically:
eSubmitter (best for low-volume submitters) or
Health Level 7 Individual Case Safety Reports (HL7 ICSR) (better for high-volume submitters)
The eSubmitter is a pre-built application that manufacturers can use to format reports for submission one at a time. If you need to submit a high volume of reports, you may choose to use the HL7 ICSR standard to submit your records via an XML file.
Both electronic submission options require the use of the FDA’s Electronic Submissions Gateway (ESG). The Electronic Submissions Gateway is a portal to securely transfer for records to the FDA. Think of it like an encrypted, secure tunnel for your information to pass from the application you choose above to the FDA’s database.
To set up an FDA ESG account, we’ve outlined the 6 step process in detail in our FDA ESG Checklist.
In order to submit through FDA ESG, a user must obtain a digital certificate. These digital certificates are used to encrypt the data that you submit as well as prevent against any tampering by a third party. For those that are unfamiliar with digital signatures, GlobalSign has representatives ready to help you through the purchase process.