FDA Final Rule on Electronic Medical Device Reporting

The FDA published a final notice on electronic medical device reporting on Feb. 13, 2014, that requires importers and manufacturers to submit medical device reports to the FDA in an electronic format that could be processed, reviewed and archived.

The two choices for submitting an electronic report are:  eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR). Importers and manufacturers Manufacturers and importers will have until Aug. 13, 2015 to begin submitting all MDR reports electronically. In case you fail to meet this date, you must request to obtain an exception from electronic reporting to continue reporting using hardcopy past August 13, 20015.

The two choices for electronic submission of reports are eSubmitter and HL7 ICSR.

E Submitter: The eSubmitter application which is developed by the FDA could be used to send one report at a time. Alternatively an entity can use the HL7 ICSR standard to develop its own application and batch reporting. E Submitter is a free and downloadable application that permits submission of only one MDR at a time. Hence this option best suits for low volume reporters.

HL7 ICSR: The HL7 ICSR submission method allows reporters to submit MDRs either as a batch or individually as XML files from their own complaint handling system.

E-MDR makes use of the FDA Electronic Submissions Gateway, (ESG), which is an agency-wide entry point for all electronic submissions, to receive electronic MDRs.  The requirements to submit MDRs electronically are:  Set up a Web Trader Account and then submit test data that is processed successfully through the FDA’s ESG before receiving a production account for MDR submission. 

The steps you must follow are: First request a Web Trader Account from the ESG. Follow the ESG instructions on compliance submission, submit and then prepare a test eMDR. The scenarios are: Receive an ESG production account, and use the production account to send your real eMDRs to the FDA.

Learn more about FDA final rule on Electronic Medical Device Reporting so your company can be ready through this webinar http://bit.ly/eMedicalDeviceReporting