Paper medical device reports (MDR) will soon be a thing of the past. On August 14, 2015, the electronic MDR final rule goes into effect, requiring manufacturers, importers and other firms responsible for reporting to submit MDRs to the FDA electronically through the agency’s Electronic Submission Gateway (ESG) rather than through paper forms, including discs or facsimiles.
As detailed in FDA’s February 13, 2014, final rule on Electronic Medical Device Reporting, FDA’s Center for Devices and Radiological Health (CDRH) has an MDR database that supports two options for electronic submission of MDRs:
- eSubmitter is FDA-developed software that allows the user to enter the report information onto an electronic version of FDA Form 3500A, which can be submitted through FDA’s ESG. The form may also be saved or printed for a firm’s internal record keeping.
- Health Level 7 (HL7) Individual Case Safety Reports (ISCR) is software developed in conjunction with the HL7 standards organization to support the exchange of electronic data. This option allows for the extraction of information directly from the reporter’s database to populate an MDR, production of the appropriate data output, and transmission of the MDR to FDA’s ESG.
The biggest difference between the two options is that eSubmitter allows for the submission of one MDR at a time, whereas HL7 ISCR supports the batch submission of more than one individual MDR at a time. Use of one submission option versus the other would likely depend on the number of MDRs that a device firm anticipates submitting over the course of time.
Significantly, the software options above only assist in preparing the submission. FDA’s ESG is separate, secure entry point for all electronic submissions to the agency so device firms must have an ESG account. Both options provide digital certificates that accompany the reports as required for all submissions through FDA’s ESG. The certificate allows FDA to authenticate the identiy of the sender and to identify encryption/decryption codes.
Under 21 C.F.R. § 803.19, a device firm may submit a written request to FDA seeking an exemption from the electronic MDR requirements. The request should include an explanation of why the request is justified, including financial hardship, and a statement of how long the exemption is needed. This writer cautions, however, that firms should not rely on FDA accepting a request for an exemption. In its electronic MDR final rule preamble, the Agency states “FDA anticipates receiving few exemption requests relating to the electronic reporting requirement because of the availability of the [i]nternet, the commercial availability of digital certificates, and free access to FDA’s eSubmitter Internet software.”
It may take some time to register and learn how to submit electronic MDRs, so now is the time to upload the software and register for an ESG account if you have not yet done so.