June 19, 2015
Looks like it’s crunch time for medical device manufacturers. Whether they submit one or 10,000 medical device reports (MDRs) to the FDA per month, they are required to go all electronic come August 14, 2015. No faxes, no mailed in reports, no more burned CDs. Device manufacturers have two choices. Either use the eSubmitter, or utilize the HL7 ICSR. Both go through FDA’s Electronic Submissions Gateway.
If device manufacturers haven’t yet setup their ESG accounts, they better get started right away. It takes at least two weeks to get on board with FDA, as well as additional time to test the submissions. FDA issued another reminder and an updated implementation package this morning:
On August 14, 2015, the eMDR final rule goes into effect, requiring manufacturers to submit medical device reports (MDRs) to the FDA electronically rather than in paper form. Electronic submission expedites report processing and reduces the burden of data entry on the FDA, manufacturers, and importers. There are two options available to all reporters for submitting eMDRs: eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR).
Today, the FDA released an updated implementation package with the system requirements to enable manufacturers that chose the HL7 ICSR submission option to prepare for and test eMDR submissions.
As a reminder, both eSubmitter and HL7 reporting options transmit MDRs to the FDA using the FDA Electronic Submission Gateway (ESG), a secure entry point for all electronic submissions to the Agency.
Manufacturers should consider registering for an ESG account and submit a test submission as soon as possible to ensure that they are electronic submission compliant by August 14, 2015, regardless of which transmission method they choose. Manufacturers may begin testing their submissions as early as June 29, 2015.
Information on the FDA ESG and steps to obtain a production account, please visit the Electronic Submissions Gateway page.
For more information about how to prepare for eMDR, please visit the FDA eMDR page.
After this deadline, there will be no more extensions. Even if device manufacturers rarely submit reports, they need to make sure they are ready just in case.
