The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a Questions-and-Answers document dedicated to the Electronic Medical Device Reporting (eMDR).

The document is intended to provide additional clarifications on the matter to all parties involved, including industry representatives, healthcare professionals, and personnel of the Agency. The latest version of the document was issued by the authority in February 2014. The regulatory requirements addressed in the document entered into force in August 2015.

Due to its legal nature, the document provides non-binding recommendations to be considered in order to ensure compliance with the applicable regulatory requirements. However, an alternative approach could be applied, provided such an approach complies with the applicable legislation and has been discussed with and approved by the regulating authority in advance.

Regulatory Background

The present FDA guidance provides additional clarifications with regard to the current regulatory framework for mandatory reports related to adverse events to be submitted by medical device manufacturers and importers. The appropriate medical device reports (MDRs) should be submitted to the regulating authority in electronic format. Once processed by the Agency, these reports will also be available for healthcare institutions. It is important to mention that the latter are allowed to submit written reports as well.

In particular, the document describes in detail how the medical device report should be prepared and submitted to the responsible center, the Center for Devices and Radiological Health (CDRH), and also provides references to additional sources where the responsible parties can find ancillary information on the matter.

For a long time, all reports related to adverse events associated with medical devices approved for marketing and use in the US were submitted in paper format only – the responsible entities had to submit paper copies via regular mail. The main deficiency of this approach is the unneeded workload for the authority as it is necessary to process the information and upload it manually in the electronic database in order to be processed further. As part of the general improvement of regulatory procedures, the FDA decided to switch incident reporting to electronic format. The Agency states that this approach significantly reduces the cost associated with the process, as well as the time needed to process an application. Additionally, it reduces the number of data entry errors.

According to the guidance, the benefits associated with the new approach to medical device reports are the following:

  • The responsible parties can reduce their expenses associated with the preparation of reports;
  • There are fewer transcription errors occurring when uploading information in the database;
  • The authority receives important information in a fast and efficient way;
  • The authority obtains the ability to respond to adverse events occurring and notify all the parties involved about the risks associated with a particular medical device.

New Approach: Main Points

The regulatory background for the new approach to medical device reports is set forth by regulation 21 CFR Part 803. The present FDA guidance provides a detailed review of the most important rules and requirements in order to assist the parties involved in achieving and ensuring compliance thereto.

Electronic MDR submissions – key aspects

According to the guidance, an eMDR submission is a file containing one or more medical device reports in an electronic format that FDA can process, review, and archive. The information to be included in an eMDR should be the same as usually provided in an adverse event report. The current regulations provide separate lists of details to be included in the reports submitted by medical device manufacturers, importers, and healthcare facilities. As mentioned, the latter are allowed to submit the medical device reports either in written or in paper format – how it was before the new rules entered into force. It is stated that the reports themselves will be uploaded in a machine-readable format. 

Submitting eMDR

According to the guidance, electronic medical device reports should be submitted via the Electronic Submissions Gateway (ESG) operated by the FDA. For this purpose, the responsible entity should have a Web Trader Account. Before submitting the actual report, the Agency encourages parties involved to submit test data. 

According to the guidance, the following procedure should be applied:

1. Request a Web Trader Account from the ESG;

2. Submit a Letter of Non-Repudiation to FDA;

3. Obtain a personal digital certificate;

4. Submit test data and prepare a test eMDR containing all the information required;

5. Receive a production account from the ESG;

6. Use the production account to send the actual eMDRs to FDA.

The document also provides references to additional guidelines dedicated to the matter. 

The FDA also describes how an eMDR could be prepared. According to the guidance, this could be performed in two ways:

  1. By using the FDA eSubmitter Software – a free tool intended for preparing downloadable files. When using it, one will have to enter all the information manually, and then the file will be generated. Additionally, the report could be printed or supplemented with additional documentation. The tool could be used to create only one report at once.
  2. By virtue of Health Level Seven (HL7) Individual Case Safety Reporting – the approach allowing to create several reports to be provided in the course of one submission. 

If the responsible entity does not have the information required in any field, the appropriate abbreviation should be used, namely: AKSU (asked but unavailable), NI (no information), NA (not applicable). If the eSubmitter does not allow to use of a null value, the field should remain blank.

Upon submission of the report, the user will receive three acknowledgments corresponding to the current processing stage. These acknowledgments include the following:

  • Acknowledgment 1, also known as the Receipt or MDN (Message Disposition Notification) acknowledgment, indicates that the ESG received the eMDR(s).
  • Acknowledgment 2 indicates that CDRH received the eMDR(s).
  • Acknowledgment 3 indicates the pass or failure status of the eMDR(s) into CDRH`s adverse event database – that is, whether the eMDR was successfully loaded into the database. 

Under the general rule, all three acknowledgments mentioned above should be provided the same day the initial medical device report is submitted or within 24 hours after. 

In summary, the present FDA guidance provides additional clarifications on how medical device reports should be provided in electronic format. The document highlights the most important aspects related to the content of the report and the particular way it should be submitted to the authority. 

Sources:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-about-emdr-electronic-medical-device-reporting-guidance-industry-user 

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