Hello. My name is Andrew Xiao and I am a Consumer Safety Officer in the Division of Industry and Consumer Education. Before I joined this division, I was a Medical Device Reporting Analyst in the Office of Surveillance and Biometrics where my entire job function revolved around the Medical Device Reporting regulations found in Part 803.
Today I will be presenting to you on Medical Device Reporting, which is abbreviated MDR. MDRs are an important post-market surveillance tool that FDA uses to ensure the safety of medical devices in the US market. Now, why should you, a member of the medical device industry, care about MDRs? Because the information gathered from MDRs can be utilized in your Quality System to improve your product, increase your market share, and decrease the money you lose from recalls and lawsuits.
Now that I have established the importance of MDRs, let me now review this presentation’s learning objectives. We need to first understand the basic MDR regulation before we can delve into the Medical Device Reporting Electronic Submission Requirements Final Rule. In the last part of this presentation, I will then review the basic process for preparing and submitting electronic Medical Device Reports, which is abbreviated eMDRs.
Now, before I begin, I just wanted to provide a friendly reminder regarding Complaint Files. The FDA regulations found in the Code of Federal Regulations Title 21 are often intertwined and this is an example of how the MDR regulations are intertwined with the Quality System Regulations. If you are unsure of the Complaint File requirements in the Quality System Regulations, then it would be highly suggested that you review 21 CFR 820.198 when you get the chance. Let’s now begin with the basic requirements found in the MDR regulations.
FDA has the authority to require mandatory medical device reports from manufacturers, importers, and device user facilities.
A manufacturer is defined as any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other means. This includes Domestic Manufacturers, Contract Manufacturers, Specification Developers, Foreign Manufacturers, Repackagers, and Relabelers. Repackagers and relablers are often not thought of as manufacturers, but FDA includes them in its definition of a manufacturer and thus manufacturer MDR requirements also apply to relablers and repackagers.
Importer means any person who imports a device into the US and who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package.
Device user facility means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility. Please note that physician's offices, school nurse offices and employee health units are not device user facilities.
Please be advised that a MDR report does not constitute an admission that the device, reporting entity, or the entity’s employee caused or contributed to the reportable event. This is an important disclaimer because without it, FDA would likely not receive enough MDR reports in order to conduct post-market trending and carry out its mission of protecting the US public health.
Now, when do MDR requirements apply? User facilities are required to report once they become aware of information that reasonably suggests that a device may have caused or contributed to a patient death or serious injury.
Manufacturers and importers are also required to report when they become aware of information that reasonably suggests that their device caused or contributed to a death or serious injury. However, manufacturers and importers have the added responsibility to report malfunctions that would likely cause or contribute to a death or serious injury if the malfunction were to recur.
At this point, you may be curious as to what is a serious injury is as opposed to a non-serious injury and you will find FDA’s definition of a serious injury in 21 CFR 803.3. However, I would encourage you to review the guidance document Medical Device Reporting for Manufacturers in the reference section to gain a better understanding of what type of adverse events are considered to be serious injuries. Similarly, that guidance document also provides information regarding MDR reportable malfunctions.
Now, let’s move on to other MDR report types and timeframes.
In addition to submitting MDRs, manufacturers are required to submit A) Supplemental reports, which are also known as follow-up reports to previously submitted MDRs, and B) 5-day reports. 5 day reports are for events that require remedial action to prevent an unreasonable risk of substantial harm and the manufacturer has 5 business days to submit this report to the FDA.
Please note that the mandatory reporting timeframes begin on the day after the mandatory reporter becomes aware of a MDR reportable event.
I like this chart because it nicely summarizes the MDR reporting requirements for mandatory reporters. This chart also tells you what types of adverse events mandatory reporters are required to report, who the event needs to be reported to, and what the timeframe is.
Manufacturers have 30 calendar days to submit MDR reports of death, serious injuries, and certain types of malfunctions. For 5 day reports, manufacturers have 5 business days, and for supplemental reports, manufacturers have 1 month to report to FDA.
User facilities are required to report deaths and serious injuries to FDA within 10 business days and importers have 30 calendar days to submit MDR reports of death, serious injuries, and certain types of malfunctions.
Now that you have a general understanding of MDR reporting requirements, let’s delve into the eMDR requirements. What is an eMDR? An eMDR is a file containing one or more MDR reports in an electronic format that FDA can process, review, and archive. Let’s now review the eMDR basics in the Medical Device Reporting Electronic Submission Requirements Final Rule
On February 14, 2014, FDA published the Medical Device Reporting Electronic Submission Requirements final rule in the Federal Register. Please note that this final rule can be accessed via the Reference section at the end of this presentation. As stated in the final rule, the eMDR requirement will take effect on August 14, 2015. If your company is not yet eMDR compliant, then it would be suggested that you plan accordingly so that your company will be eMDR compliant by August 14, 2015. Please, please, please do not wait until August 14, 2015 to begin the process of becoming eMDR compliant.
The final rule also stated that manufacturers and importers will be subject to eMDR. Specifically, manufacturers must submit initial and supplemental reports to FDA in an electronic format that FDA can process, review, and archive. Similarly, importers must also submit initial reports to FDA in an electronic format.
User facilities will continue to submit reports to FDA and the manufacturer in a paper format via FDA Form 3500A.
Please note that this final rule did not change what must be included in a MDR report or when the report should be submitted. The primary change that will take place on August 14, 2015 is that the method for submitting MDRs to FDA has changed for manufacturers and importers from paper to an electronic method.
The final rule also made changes to recordkeeping requirements. The final rule amended Part 803 to require eMDR submitters to retain all paper or electronic copies of the eMDRs submitted. Please note that firm may choose whether the copies are retained via paper or electronic means.
Furthermore, all acknowledgements that FDA sends to manufacturers need to be retained and I’ll discuss what acknowledgements are in a few slides.
Now that you understand the MDR and eMDR regulatory requirements, I will now review the basic process for preparing and submitting eMDRs to FDA.
eMDRs that are submitted to the FDA are received by the Electronic Submission Gateway, which is abbreviated as ESG. The ESG is the central transmission point for sending information electronically to the FDA. In addition, the ESG acts as a secure entry point for all electronic submissions sent to the FDA and the ESG then relays the product specific report to the appropriate FDA center, which in the case of eMDR is CDRH, the Center for Devices and Radiological Health.
In order to submit eMDRs to the ESG, the submitter will be required to receive a digital certificate from FDA and I will elaborate further on this point when I discuss Web Trader information.
Now that you understand the basics of the ESG, let’s now briefly delve into what happens next. Once an eMDR is received by FDA’s ESG, then it will automatically send Acknowledgment 1 to the submitter and Acknowledgment 1 indicates that the eMDR submission was received at the FDA ESG.
The eMDR report is then sent to CDRH database whereupon the CDRH database automatically sends Acknowledgment 2 to the submitter. Acknowledgment 2 indicates that the eMDR submission has reached CDRH.
Once CDRH’s database receives the eMDR report, the database will attempt to load the eMDR report into the adverse event database. At this point, the database will automatically send Acknowledgment 3 to the submitter to indicate the pass or failure status of the submitted eMDR into CDRH’s adverse event database. I’ll talk about what you can do if you receive the Acknowledgment 3 failure status in the next slide but please note that if there are no errors, the three acknowledgment letters will be generated within 24 hours of submission.
Now that you understand the process of generating acknowledgment letters, let’s discuss who you should contact in cases there are issues with any of the acknowledgment letters. I have provided a link in the references section that you can utilize to check the status of the ESG. If the ESG system status website indicates the ESG is operating normally and you did not receive Acknowledgment 1 or 2, then please contact the ESG Staff at the email address stated.
I have also provided a link in the references section that you can utilize to check the status of the eMDR System. If the eMDR system status website indicates eMDR is operating normally and you did not receive Acknowledgment 3, then please contact the eMDR Staff at the email address stated. If you received an Acknowledgment 3 error message, then please fix the error in the eMDR report that you submitted and then resubmit the eMDR to FDA. If you do not understand the Acknowledgment 3 error message for an adverse event reports submitted to CDRH and need help interpreting the error, then please contact the eMDR staff for interpretation.
Now that you understand the big picture of how an eMDR is submitted to FDA, let’s discuss how you can obtain a Web Trader account from the ESG in order to submit eMDRs to the ESG. Please follow the instructions in the link Setting up a Web Trader Account Checklist in the references section below. You will note that there are preparatory activities, such as obtaining a digital certificate, that you will have to perform in order to setup a production account. Regardless, please follow the instructions in setting up a Web Trader account.
During the process of setting up a Web Trader account, you may have questions or require assistance. For policy questions and to request a WebTrader account, please contact the FDA through the email address stated. For assistance with the registration or testing process, please contact the ESG staff at the email address indicated.
When you have the electronic infrastructure in place in order to submit eMDRs to FDA, then please be advised that there are two methods of submitting eMDRs to FDA. The first method is via eSubmitter and this method allows reporters to submit eMDRs individually. Please note that eSubmitter is a free software that you can download from the FDA. In the references section, I have provided a link titled eSubmitter Download and Installation that you can use to download the eSubmitter software. As such, eSubmitter acts as a standard software that eases the technical eMDR reporting burden on manufacturers and importers. Furthermore, eSubmitter generates an electronic version of FDA Form 3500A in zip file format, which is then sent to FDA via the ESG. You will be able to save or print this electronically generated version on your computer. Lastly, please note that eSubmitter will also allow attachments to be included in an eMDR submission.
The second method for submitting eMDRs to FDA is through Health Level 7, which is abbreviated HL7. HL7 is a standard for the capture of the information needed to support the submission of MDR reportable events. HL7 allows reporters to extract information directly from the reporter’s database to populate an eMDR submission and for the transmission of the eMDR submission to the FDA ESG. As such HL7 allows eMDRs to be submitted in large batches or even one at a time.
Firms that chose to submit eMDRs using HL7 will need to develop their own custom eMDR solution using HL7. Furthermore, firms that chose to use HL7 as their method of submitting eMDRs are encouraged to develop capabilities for saving and printing submitted reports and their attachments.
If you would like additional information regarding HL7, then please utilize the link Health Level Seven Individual Case Safety Reporting in the reference section.
Okay, I have covered the basic MDR regulation and provided an overview of the Medical Device Reporting Electronic Submission Requirements Final Rule. I then reviewed the basic process for preparing and submitting eMDRs to FDA. Let me now reemphasize three major points from this presentation. Point one: Please do NOT wait until August 14, 2015 to get an ESG account! I cannot emphasize this point enough. Point two: The method for submitting MDRs to FDA has changed. However, other MDR requirements have generally not changed. Point three: eSubmitter & HL7 are two methods that you can use to submit eMDRs to FDA.
This is the references section that I have alluded to in my presentation.
It would be suggested that you review the information in these links.
These webpages will allow you to gain a stronger understanding of the material that I have covered in this presentation.
In addition, Device Advice and CDRH Learn are two great resources for industry education.
If you would like to contact the Division of Industry and Consumer Education, then please note our contact information here.
If you need help interpreting MDR policy or would like to requests an exemption, then please contact the MDR Policy Branch. You can find their contact information here.