A couple of weeks ago, a long-time reader of Devine Guidance suggested that Dr. D expand upon the virtues of electronic reporting and the final agency rule associated with eMDRs. This week, the doctor will do just that. Not wanting to “filch” (look-it-up) but feeling obliged to do so; on 13 February 2014, the final rule amending 21 CFR, Part 803 (reference 79 FR DOC 2014-03279) was announced. When the sun rises on the eastern seaboard of the United States on August 14th 2015, device manufacturers and importers, entering devices into commerce in the United States, had better be employing at least one of the two reporting options offered by FDA: (a) eSubmitter; or (b) Health Level Seven Individual Case Safety Reports. For medical device user facilities (e.g., hospitals), the option to continue to kill trees remains on the table as user facilities can still employ the filing of paper MDRs; although Dr. D is not sure why one would continue to do so. That being said, the doctor hopes you enjoy this week’s guidance.
Why, Why, Why?
For some reason, many people believe the entry of data into the MAUDE database is a magical process consisting of the sprinkling of pixie dust onto hard-copy MDRS that instantly extracts data from the MDR and places it into a database. Sorry folks but the process actually requires the use of manual labor to physically perform data entry tasks needed to upload data extracted from paper copies. Guess what? Manual data entry is a process that occasionally results in data-entry errors, a.k.a., “transcription” (look-it-up) errors. Besides, it is a time consuming process and considering our government’s ongoing “penchant” (look-it-up) to waste taxpayer’s dollars on stuff we do not want or need, the moving of the data entry burden from FDA to device establishments will save the agency some coin. Benefits expected to be realized are:
- A reduction in time (time is money) associated with processing paper reports by industry and the agency;
- A reduction in FDA transcription errors (now industry gets to make the errors);
- Faster access by FDA to data relevant for identifying negative trends associated with device safety and efficacy issues; and
- The ability for FDA to rapidly communicate to industry when device problems are noted.
Data required to be entered into an eMDR
Dr. D is going to punt here and just state; “Read 21 CFR, Part 803.” The required data is not changing just the tool employed for agency notification. As previously mentioned, device manufacturers will be required to comply with the electronic filing requirement come August 2015. However, user facilities can choose to use the electronic filing approach or continue to send paper copies.
Submission basics via the Agency’s Electronic Submissions Gateway (ESG)
Not unlike an email account, establishments will need to create a “Web Trader Account” with the ESG. It is important to understand establishments must successfully send test data before being granted access to file eMDRs. In fact, there are multiple steps that establishments must complete prior to being granted access. The entire process, from a 50,000’ perspective consists of:
- The initial request of a Web Trader Account from ESG;
- The submission of a “Letter of Non-Repudiation” (reference 21 CFR, Part 11.100)
- The submission of a personal digital certificate, to authenticate the identity of the sender;
- Successfully complete the submission of a test message process;
- Wait for notification from EGG that your account is available for use (note: requires CDRH approval first); and
- Have fun by commencing with the loading of your establishment’s first eMDRs.
The agency is well-aware that there are slackers out there in industry so the FDA has graciously provided a path for requesting an exemption “in writing” prior to 13 August 2015. For those Chief Jailable Officers (CJOs) willing to proceed down that precarious path of exemption, you better have a pretty darn-good reason for doing so.
Two options for submissions
As Dr. D previously mentioned, there are two paths for electronic submissions. The first is FDA eSubmitter, a free program that can be downloaded from FDA. The eSubmitter program allows the user, once an account has been created, to manually enter MDR data into the program. The good news is that program aligns with 21 CFR, Part 803 so the user should always be able to enter the required data; however, data accuracy is the burden of the user. Even better, the user can actually print copies of the transmitted MDRs and attached supplemental reports, as necessary. But wait there is more. The agency also provides installation instructions for free.
The second pathway is the Health Level Seven Individual Case Safety Reporting option. This second option permits users to file individual MDRs or batches of MDRs. Note: It is Dr. D’s opinion; depending on the size of the batched of MDRs, this option may quickly garner agency attention. Additionally, FDA strongly suggests that “Entities who choose this option are encouraged to develop systems that can save or print the resultant report and that can encode attachments into their eMDRs.”
The doctor is going to leave the readers with just one takeaway for this week’s guidance. Embrace this change. The use of electronic filing will make your lives easier. Considering the initial requirement to report deaths and serious injuries was born in 1984, it is about time industry moved into the 21st century in regards to the reporting of adverse events. Dr. D is a big proponent of any type of e-tools that makes life easier for device establishments. Besides, for you tree huggers out there, it is nice to do something good for the environment for a change.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2013, April). Title 21 Part 803: Medical device reporting. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Questions and answers about eMDR – electronic medical device reporting guidance for industry, user facilities and FDA staff. (2014, February). Washington, D.C.: U. S. Government Printing Office.