FDA Sets Importer Requirements for Electronic Reporting of Device Adverse Events by 2015
The Food and Drug Administration is requiring electronic reporting of adverse events related to medical devices, in a Feb. 14 final rule. Beginning Aug. 15, 2015, manufacturers and importers of medical devices must electronically submit medical device reports (MDRs) of deaths, serious injuries, and malfunctions, as well as supplemental or follow up reports, through one of two FDA systems. Only importer MDRs submitted directly to FDA are required in an electronic format; importer MDRs submitted to device manufacturers may still be in paper form. In conjunction with its final rule requiring electronic submission of MDRs, FDA posted a guidance containing questions and answers on the new requirements (here).
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The final rule “does not change the underlying reporting requirements, just the manner in which they are submitted to FDA,” said the FDA. “When manufacturers and importers submit data elements to FDA in a paper format, the information must be manually entered into our internal electronic database before it can be effectively reviewed and analyzed,” it said. “Under the [final] rule, this data entry will be performed by the manufacturers and importers and they will save the cost of submitting the paper forms. More importantly, eliminating that step will make the information available more quickly to FDA.”
Submitters Have High- and Low-Volume Options
Beginning in August 2015, electronic MDRs will have to be submitted to FDA in one of two ways. Single reports can be prepared using agency’s eSubmitter software, which develops an electronic version of FDA Form 3500A that can then be submitted through the FDA Electronic Submission Gateway (ESG). On the other hand, reporters of large numbers of MDRs can submit batches of reports using the Health Level 7 Individual Case Safety Reports (HL7-ICSR) system, which extracts the information directly from the user’s database, converts it, and transmits it to FDA’s ESG. Both types of submissions to FDA’s ESG require the submitter obtain a digital certificate (here).
Once an MDR is submitted, FDA will send the submitter three different acknowledgment messages for each submission: a message from the ESG that says the MDR was successfully submitted to the system; a message from the ESG that says the MDR was forwarded to the Center for Devices and Radiological Health (CDRH); and a message from CDRH sent through the ESG that says that the MDR was successfully uploaded into its database, or that it contains errors that need to be corrected. If there were no errors, all three messages should be sent within 24 hours of submission, said FDA.
Recordkeeping. Submitters of MDRs will have to maintain copies of all reports in either paper or electronic form, says the final rule. All acknowledgment messages received from FDA must be maintained in records as well, said FDA.
Exemptions Available From Electronic Reporting
Under the final rule, manufacturers and importers may request exemptions from the electronic reporting requirement. The written request must explain why the exemption is justified, such as financial hardship, and must specify how long the exemption is needed. If granted, FDA will allow paper submission of MDRs until the exemption period ends. However, the agency says it expects to get very few requests for exemptions, given the availability of the internet and digital certificates, and free access to FDA’s submission systems.
(Federal Register 02/14/15)