Normally, "are we there yet?" is the annoying question kids, and some adults, ask during a drive to a summer vacation spot. As summer comes to an end, "are we there yet?" is also a good question for your company to consider with regard to two initiatives currently underway at FDA: eMDR and Event Problem Code changes.
If you are not one of the companies already submitting electronic MDRs, what do you need to know to make eMDR a reality for your company? First, eMDR is not going away. I repeat, it is not going away. It offers many benefits for both FDA and Industry. First, it reduces the number of days for delivery of adverse event information to FDA. Next, it eliminates the hand entry of the MDR data into the FDA Manufacturer and User Facility Device Experience (MAUDE) Database by FDA Staff. Finally it reduces the amount of paper required to comply with 21CFR Part 803 and reduces the courier charges to send the paper form to FDA. This reduction of paperwork also makes your company more eco-friendly.
Next, you need to know where you can find the information you need to prepare for eMDR. The good news is that all the information you need can be found on the FDA's website. The website has recently been updated to be more user-friendly so if you have certain links saved in your favorites, they may no longer work. The link for the main eMDR webpage is http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
/ReportingAdverseEvents/ucm127932.htm. From here, you can find almost any information related to eMDR that you will need.
Chart 1 shows the basic flow of eMDR data.
The FDA Gateway is the Agency-wide point of entry for all electronic submissions, including eMDRs. As you can see from Chart 1, there are two different options that a company can select to submit the electronic MDR data to the FDA Gateway. The first is the FDA eSubmitter option. eSubmitter, which is a free software package available from FDA, allows electronic completion and submission of MDR information using an electronic FDA Form 3500A. Once the information is added to the form, the eSubmitter software does all the work for you. It translates the data into the correct format for the electronic submission to FDA and sends the data via the FDA Gateway. There are also features built into the software which help to maintain the quality of the data to ensure a successful submission. For example, a "missing data" report ensures all required fields of the form are completed before submission to FDA. There is also a tool that allows you to save address and contact information so you don't have to re-type it for every submission.
The FDA eSubmitter option is good for companies that have a low volume of MDRs. There is minimal work to get started and you only need a basic understanding of what is happening behind the scenes. This option does require manual completion of the MDR form so auto population of fields with data from your database is not possible. However, as previously stated, there are tools incorporated in the software to help maintain the quality of the data and to ease data entry.
The second option for eMDR is the high volume option via the Health Level 7 (HL7) Individual Case Safety Report (ICSR). With this option, MDR data can be extracted from your adverse event database and formatted to the HL7 ICSR standard for submission. This option permits electronic submission of individual or batch reports and is more suited for device manufacturers that have a high volume of MDRs. Although, this option does require an extensive amount of internal development and technical expertise, it allows you to utilize information directly from your current database.
Both options listed above are open to all reporters regardless of reporting volumes. The decision for which option is used is left up to the reporter. So whichever option you use, the eMDR submission is routed via the FDA Gateway, to CDRH and then on to the MAUDE Database.
Similar to eMDR, the FDA Gateway or ESG, also provides two options for submission. Option 1, using Webtrader, provides a webportal where reporters can submit one MDR at a time. Option 2 involves establishing a business to business (B2B) connection between the FDA Gateway and the reporter's gateway. With the B2B option, reporters 'drop' eMDRs into the appropriate outbound folder on their gateway website which are then transferred to the FDA Gateway. Both options are available to all reporters. For more information, please visit http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm.
During the submission process you will receive three acknowledgements from FDA. Acknowledgment 1 is sent by the Gateway to confirm that the submission was successfully received by the Gateway. Acknowledgement 2, also sent by the Gateway, confirms that the submission successfully reached CDRH. Finally, Acknowledgement 3, sent from CDRH, confirms that the submission is successfully loaded into the MAUDE Database, or it notifies you of any errors that prevented the data load to the MAUDE Database. These acknowledgements are important because they will provide evidence that you have submitted the MDR within your 30-day window. Also, when you receive errors, the acknowledgements will help you determine how to troubleshoot your submission.
The current thinking on acknowledgements is that as long as you have a successful submission, Acknowledgement 1 can be used as the time stamp for receipt of your submission. What this really means is that if Acknowledgement 3 is successful, and has confirmed that your data is safely in the MAUDE Database, you can use Acknowledgement 1 as the date of submission to FDA. If Acknowledgement 3 fails, you must correct the errors and resubmit the data. You will then receive a new set of acknowledgements. If the new Acknowledgement 3 is successful, you will use the new Acknowledgement 1 of your resubmission as your date and time stamp.
Now that you have done your homework and selected which eMDR option fits the needs of your company, what are the next steps? You must register with FDA as a "trading partner." A trading partner is an external entity authorized by FDA to submit electronic submissions. To register and request a test account email email@example.com.
You will also need a letter of non-repudiation and a digital certificate. The letter of non-repudiation states that your company intends that electronic signatures executed by employees are the legally binding equivalent of traditional hand-written signatures. A digital certification verifies that the person sending an electronic message is who he or she claims to be.
Once you receive your test account you will test multiple scenarios as defined by FDA. You need to work closely with the FDA eMDR Team during testing. So before you begin the testing phase of your eMDR implementation project, please contact the eMDR Team to schedule testing. If testing is successful, you can apply for a production system account using the same process as you did to obtain the test account. During the test phase you should also evaluate which of your internal procedures may need updating as a result of changes made to support electronic submission of MDRs. One additional consideration is how the acknowledgements will be saved and retrieved when evidence of meeting reporting timelines is required. Once you have completed these steps, you are one step closer to answering "yes" to the question "are we there yet?"
The good news is that FDA will accept the new codes as of July 1, 2009. They will also continue to accept the codes that were made inactive until April 1, 2010. As of April 2, 2010, FDA will not accept the inactive codes or code numbers. Additional information regarding the Event Problem Code changes, including Excel files with the updated codes, can be found at the following webpage: http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/EventProblemCodes/default.htm.
FDA Gateway webpage:
Event Problem Code Webpage:
Rae Ann Farrow is a Director of Regulatory Compliance at Roche Diagnostics in Indianapolis, Indiana. She has more than 15 years' experience in the Medical Device Industry, in both pre-market and post-market activities. Her current responsibilities include eMDR implementation.