FDA Proposes Mandatory Electronic MDRs

The FDA has proposed new rules requiring electronic MDR submissions for device manufacturers. The proposed rules, published in the August 21 Federal Register, are open for comment until November 19, 2009.

The proposed rules amend 21 CFR Part 803. In addition, the FDA has developed a draft guidance document that describes how to submit electronic MDRs in the new program called eMDR.

Low-volume reporters (few or infrequent reports) can use the CDRH eSubmitter (CeSub) software, to submit one report at a time. With CeSub, you manually enter all the pertinent MDR report information into the CeSub program. The program produces the message needed to transmit the report to FDA. The CeSub program also permits you to print a copy of the submitted report. The CeSub software and instructions for installation are free.

High-volume reporters (numerous or frequent reports) can develop an application using the prescribed FDA format to create an electronic MDR submission directly from adverse event information in the reporter’s computer system. The file may contain multiple reports in a single submission.

The proposed rules do not change the required timeline for reporting. Events must be submitted within 30 calendar days of the manufacturer’s becoming aware of the event. Events which require remedial action must be filed within 5 working days.

The proposed rules may be found at www.regulations.gov under Docket Number FDA–2008–N–0393.

The draft guidance document may be found at www.regulations.gov under Docket Number FDA-2008-D-0395.

The draft Guidance Document may also be obtained from the FDA at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm175805.htm