|February 24, 2014|
Previously published on February 19, 2014
On February 14, 2014, FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit MDRs in an electronic format (the “Final Rule”). 79 Fed. Reg. 8832 (Feb. 14, 2014). The Final Rule does not materially change the underlying requirements for reporting MDRs. Id. at 8833. It simply requires reporting of the information electronically as an electronic MDR (or eMDR). Id. Manufacturers have been able to voluntarily submit MDRs electronically since 2008. Id. Additionally, on the same day, FDA issued the Final Guidance Document “Questions and Answers about eMDR - Electronic Medical Device Reporting” (the “Guidance”). FDA, Guidance for Industry, User Facilities and FDA Staff, Questions and Answers about eMDR - Electronic Medical Device Reporting (February 2014).
The original draft of the Final Rule was proposed on August 21, 2009. 74 Fed. Reg. 42203 (Aug. 21, 2009). The most significant change between the proposed and Final Rule is that user facilities are not required, but are encouraged, to submit MDRs electronically. 79 Fed. Reg. at 8832. The Agency believes that electronic submission of MDRs will improve its ability to collect and analyze such reports as it will make the information available more quickly. Id. at 8833.
The Final Rule is a complete (but primarily non-substantive) revision of 21 C.F.R. Part 803, as there were too many changes to call out each one separately. Although a number of clarifying changes have been made, the one significant substantive change is that manufacturers and importers are required to submit initial and supplemental MDRs and follow-up reports to the FDA electronically. FDA is also encouraging submitters to provide responses to requests for additional information for an MDR electronically. Guidance at 8. The Final Rule will take effect on August 14, 2015. 79 Fed. Reg. at 8832. Thus, medical device manufacturers and importers have eighteen months to revise their MDR procedures to comply with the new regulatory requirements.
Electronic MDR submissions can be accomplished through two different mechanisms, either by using FDA’s eSubmitter software for submission of a single report (low volume reporting) or Health Level 7 Individual Case Safety Reports (HL7 ICSR) for submission of batch reports (high volume reporting). Id. at 8834. The eSubmitter software can be downloaded for free from FDA’s website. The software generates an electronic version of Form 3500A. Id. The electronic report can also be printed and saved for archiving purposes. Id. The HL7 ICSR is intended for use by reporters with large numbers of MDRs. Id. This option extracts information directly from the reporter’s database to populate the eMDR. Id.
In both cases, once the eMDR has been completed, it is submitted to FDA using the FDA Electronic Submission Gateway (ESG). Id. The ESG is “a secure entry point for all electronic submissions to the Agency.” Id. In order to use the ESG, the reporter must have a digital certificate, which is an attachment to the electronic message that authenticates the identity of the sender. Id. In addition, the submitter will need to set up a Web Trader Account and submit test data through the ESG before the submitter can receive a production account. Guidance at 3. It is not clear how long the account set up and test process will take or when companies will begin receiving production accounts. Therefore, reporters should work with their IT groups to ensure that they have the required digital certificate and that the test data has been submitted successfully prior to the Final Rule taking effect.
Once the eMDR is submitted to FDA through the ESG, FDA will send the submitter three different acknowledgement messages, all of which must be maintained as part of the MDR file pursuant to new 21 C.F.R. § 803.18(b)(1)(iii). 79 Fed. Reg. 8834-8835. Acknowledgement 1 indicates that the submission was received at the ESG. Id. at 8834. Acknowledgement 2 indicates that the submission reached CDRH. Id. Finally, Acknowledgement 3 notifies the submitter that the submission was either successfully loaded into CDRH’s adverse event database or that the submission contained errors, which will be specified in the letter. If a submitter receives a notice that there were errors, the submitter will need to correct the file and re-submit. If there are no issues, FDA expects that all three Acknowledgement letters will be sent on the same day or within 24 hours of the submission.
We are concerned that FDA has not stated how long it expects it will take to send the three Acknowledgement letters if there are loading issues in the final step because, as we will discuss below, the successful loading of the MDR directly relates to its “receipt date.” Hopefully, we will not experience the same e-copy issues with the eMDR system that have been experienced with the e-copy requirements for device pre-market submissions since the eMDRs will be created through FDA’s own software (it is interesting that electronic MDRs are eMDRs, but an electronic copy of a pre-market submission is an e-copy, why not e-MDRs?).
The most notable part of the new eMDR submission requirement is the change to the “receipt date” for the eMDRs. Guidance at 5-6. Submitters will no longer be able to submit their reports on the last day allowed under the regulations, and rely on the date stamp, because the “receipt date” for purposes of a company’s timely reporting of MDRs will be the date that Acknowledgement 1 is received, but only if the eMDR is ultimately successfully loaded at CDRH (thus, a successful Acknowledgement 3 is received). Id. If a failure occurs during loading (an unsuccessful Acknowledgement 3 is received), the submitter will need to resubmit the eMDR with the necessary corrections, and the “receipt date” will be the date of the new Acknowledgement 1 (yes, you will receive 3 letters with each and every submission) when the eMDR is successfully loaded. FDA will consider the local time of the submitter when determining the submission date. Id. at 6.
By way of example, this means that if a manufacturer submits their eMDR on the 30th day and the automated system does not deliver Acknowledgement 1 until the following day (the 31st day), the eMDR will be late. Alternatively, if the manufacturer submits their eMDR on the 29th day, but receives an Acknowledgement 3 indicating that there were errors in the loading process on the 30th day, that the manufacturer will need to resolve the loading issues (assuming that the technical issues can be resolved in such a short time frame) and resubmit the eMDR that day in order not to be late. We anticipate that there will be a number of late eMDRs as this process takes effect. We also imagine there will be many companies frantically trying to resolve technical issues on the 30th day. We will be interested to see if FDA issues a warning letter citing a company for a late eMDR under this system. Even more interesting will be the first company that responds to such a warning letter explaining that their eMDR was submitted within the 30 day window, but due to “loading” issues, the Agency refused to acknowledge receipt. Furthermore, one can imagine scenarios in which many eMDRs are late due to malfunctions or bugs within FDA’s software or the ESG.
Lastly, in the Guidance, FDA states that it is committed to providing industry with adequate notices of system outages and changes to the submission software. Id. at 8. In our view, the Final Rule and Guidance have been well thought through and considers the main questions that industry will need answers to as it implements the new eMDR requirements. However, we expect (as is common with all new systems) that there will be bugs to work out in August 2015 when the eMDR requirements take effect.