How the New FDA Final Rule and Guidance on Electronic Submissions Will Impact Devicemakers

The FDA Final Rule and Guidance Make 
eMDRS Mandatory Next Year.
In February of 2014, the FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit initial and supplemental MDRs in an electronic format, rather than in paper form through Form FDA 3500A. The “Final Rule” will take effect on August 14, 2015, which means you have only 13 months to revise your MDR procedures to comply with the new requirements and to secure a production account for submitting eMDRs to the FDA. Will you be ready?   
 What Has Changed?

The most substantive change, of course, is that manufacturers and importers are required to submit initial and supplemental MDRs, as well as corresponding follow-up reports, electronically. The final rule does not change the underlying reporting requirements, just the manner in which reports are submitted.

The original draft of the final rule, which was proposed in 2009, called for user facilities, as well as manufacturers and importers, to submit reports electronically. Upon further review, the FDA decided to allow facilities to continue to submit written reports, citing prohibitive costs as the reason for the exemption. The final rule states, “User facility reports submitted to device manufacturers may also be in paper format or electronic format that includes all required data fields to ensure that the manufacturer has all information.” Annual reporting has not been affected; user facilities will continue to submit annual reports on the paper Form FDA 3419.
One of the more notable changes of the new eMDR submission requirement is the change to the “receipt date.” Under the new system, the FDA has up to 24 hours to acknowledge receipt of your submission, which means you can no longer submit your reports on the last day allowed under the regulations, relying on the date stamp to prevent your submission from being considered late—and to avoid a warning letter. 

Aside from the changes listed above, as well as a number of clarifying changes, the final rule is quite similar to the 2009 proposed rule.

Two Ways to Submit Your Report

You can submit your reports to the FDA in one of two ways: through the eSubmitter tool, which can be downloaded for free from the FDA’s website, or the Health Level 7 (HL7) Individual Case Safety Reporting (ICSR)tool. The latter is intended for use for high volume reporting, i.e., batch records, while the former is for low volume reporting, i.e., single reports. The HL7 ICSR option will extract information directly from your database to populate the eMDR. The FDA is encouraging reporters who intend to use this option to develop systems that can save, print, and attach documents, e.g. photos or labeling, to their records.

Regardless of the method you choose, completed eMDRs must be submitted to the FDA using the FDA Electronic Submissions Gateway (ESG). Use of the ESG requires obtaining a digital certificate, as well as setting up a WebTrader Account, the online mechanism reporters use to upload their eMDRS to the FDA. Make sure you work with your IT department to get these requirements in order well in advance of August 14. Rest assured, many devicemakers will be scrambling on August 13 and you don’t want to be one of them. More information about ESG and obtaining digital signatures is available here.
Questions and Answers about eMDR—Electronic Medical Device Reporting, the Q&A guidance document that was released along with the final rule, provides step-by-step instructions for preparing and submitting your MDR. It also provides detailed instructions for setting up a WebTrader account, which you can pass along to your IT department. Other things covered in the document are: how to update reports, how to tell if your submission was successful, and how to handle system outages.

What to Do Now

The final eMDR rule seems to strongly suggest the FDA’s interest in moving toward an electronic submission standard. With the release of the new guidance, it’s a good time for organizations still using a paper-based or hybrid QMS to consider switching to an automated system. Now is the time to educate your organization about why the FDA is moving toward mandatory digital submission—it’s faster, cheaper, less prone to error, and “is an important set toward improving the Agency’s systems for collecting and analyzing postmarket MDRs.”

Lisa Weeks, a marketing communications specialist at MasterControl Inc., writes extensively about technology, the life sciences industry, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med