The Food and Drug Administration (FDA) has announced new improvements to the electronic Medical Device Reporting (eMDR) system to simplify uploading data and storing information related to adverse events associated with medical devices. The amended rules would be also applicable to adverse events associated with medical devices marketed in the US under the Emergency Use Authorization (EUA) in the context of COVID-19.
Regulatory Background
As set forth by the applicable regulation, the medical device manufacturers and their authorized representatives, including the importers, suppliers, and distributors would have to submit the reports on adverse events in electronic format. The Agency states that utilizing this approach would help the FDA to simplify and accelerate all regulatory procedures associated with medical device adverse event reporting. However, the new reporting system is still in the process of development and implementation. For instance, under the current changes, the FDA expanded the scope of information to be included in the submission by adding the appropriate fields. Another important point related to the special adverse event codes to be used to make the information exchange more accurate and easy.
According to the official guidance dedicated to the eMDR system, the project in general is designed to simplify the procedure of submitting medical device adverse event reports in the electronic form. There are two potential ways to be used for submitting the reports based on the frequency of reporting:
- Low-volume reporting could be performed via the eSubmitter software – a special tool developed by the Center for Devices and Radiological Health (CDRH).
- High-volume reporting could be performed using the XML files via the Health Level Seven (HL7) Individual Case Safety Report (ICSR) standard. The whole full set of information necessary to submit the information using this approach is available on the eMDR website.
The FDA guidance on the eMDR system provides a general overview of the project, as well as technical information and implementation details.
Health Level Seven: Key Points
As it is stated in the FDA guidance, Health Level Seven is a special non-profit organization aimed at the development of the applicable standards. The HL7 comprises various industry representatives and constitutes one of Standards Development Organisations (SDOs) duly accredited by the American National Standards Institute (ANSI) to carry out the standards development. In particular, the activity of HL7 is focused on the standards related to the clinical and administrative data. This organization develops messaging standards to be used to communicate information about adverse events associated with medical devices.
The Individual Case Safety Report (ICSR) is a special standard developed by the HL7 and intended to be used for reporting adverse events. At the moment, the ICSR could be used for messages related to drugs and medical devices, while later its scope would be extended to veterinary products and cosmetics. The standard should be used to report individual cases even for safety reporting between public health organizations located in different countries.
FDA Electronic Submissions Gateway (ESG)
The whole system of electronic medical device reporting is currently based on the use of the FDA Electronic Submissions Gateway (ESG) allowing the authority to receive submissions from the entities involved in operations with the medical devices. The ESG could be used for filing the regulatory submissions in a secure environment simplifying all procedures related to safety communications. The use of the system allows ensuring that any medical device safety communication has been duly received by its recipient in time, and both parties have an appropriate confirmation.
According to FDA guidance, when the entity files safety communication, the following process commences:
- The FDA ESG receives an incoming submission,
- The ESG provides a confirmation (acknowledgment) in a form of a Receipt or Message Delivery Notification (MDN).
- The request (submission) is being transmitted to CDRH.
- Upon receipt, CDRH provides the second confirmation of safe delivery.
- CDRH processes the information contained in the submission, uploads it to the Adverse Event database, and provides the third confirmation.
Thus, the entity filing the submission will receive three consecutive confirmation reflecting each milestone of the process.
It is also important to mention that in order to ensure the correct processing of the submission, the information included in the submission should be provided using common terminology.
Health Leven Seven Version 3
The HL7 Version 3 defines the data to be exchanges, the appropriate timing, and also the ways of dealing with the errors to the applications. It also covers such aspects as security checks, participant identification, availability mechanism, negotiations, and data exchange structuring. Thus, the HL7 version constitutes an important part of medical device adverse event reporting.
When describing the way the HL7 should be applied, the FDA emphasizes the following key points to be considered:
- The utilization of a standard approach allows to provide additional clarity and reduce the risk of miscommunication,
- All communications should be performed in accordance with the appropriate guidelines,
- All submissions should be aligned with the standards acceptable in the healthcare industry,
- The submissions should be made using the Extended Markup Language (XML).
One of the most important concepts introduced by the HL7 version 3 is the Common Message Element Type (CMET) – a technical tool used to achieve sufficient accuracy for all descriptions the adverse event report contains. It could be used to form data structures indicating such details as the information about the patient, location, or organization engaged.
Summarizing the information provided here above, the present FDA guidance provides medical device manufacturers and other parties involved in operations with medical devices with additional clarifications and recommendations regarding the way the electronic Medical Device Reporting framework should be applied. In particular, the Agency describes the most important elements and concepts of adverse event reporting systems, including the Health Level Seven non-profit organization and Individual Case Safety Reports. The FDA also describes in detail the aspects related to the FDA Electronic Submission Gateway, and the process performed when the submission filed by the reporting entity passes all the steps including its processing by CDRH and the appropriate confirmation (acknowledgments) to be received by the reporting entity.
Aside from general clarifications regarding regulatory compliance, the FDA guidance on electronic Medical Device Reporting also highlights certain technical aspects to be considered when filing the adverse event submissions. In particular, the document outlines the requirements on terminology to be used to ensure the accurate interpretation of the information contained therein by both people and computers. The FDA emphasizes the importance of using harmonized terminology.
The present FDA guidance actually constitutes a part of the whole eMDR implementation documentation set published by the Agency, and the information it provides is mostly of technical nature. The document was published by the FDA together with the additional technical documents and manuals dedicated to specific computer programming aspects.
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