eMDR System Unavailable – August 6 – 10, 2015

From August 6 to 10, 2015, the FDA’s electronic Medical Device Reporting (eMDR) system will be undergoing scheduled maintenance. During this time, the FDA will not be accepting Medical Device Reports (MDRs) electronically, but you may submit MDRs through FDA Form 3500A or submit electronically prior to August 6th or after August 10th.

As a reminder, on August 14, 2015, the eMDR final rule goes into effect, requiring manufacturers to submit medical device reports 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.

For more information about the eMDR requirements, please visit the FDA eMDR page.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health