In a recent bulletin, FDA communicated that updates to the eMDR previously announced in May 2020 were complete. The changes include:

• The addition of new fields for exemption number, summary report, number of events and combination products.
• An updated list of device component and adverse event codes which reflect harmonization with the International Medical Device Regulators Form (IMDRF). The deadline for use of the codes has been extended to February 28, 2021.

But that’s not all. Changes were also made to the public MAUDE database in order to make the Patient problem code and marketing submission number fields visible. (MAUDE: Manufacturer and User Facility Device Experience)

If you are marketing products during this pandemic through EUA (Emergency Use Authorization), you will want to stay abreast of FDA’s recent updates to the FAQs for adverse event reporting.

Electronic Medical Device Reporting (eMDR)

Electronic Medical Device Reporting (eMDR)

Collection of adverse event information on medical devices is mandated by Medical Device Reporting (MDR) requirements of the Food Drug and Cosmetics Act (FD&C Act) (21 USC 360i), and comes primarily from manufacturers, user facilities, importers and voluntary reporters. Currently a majority of these reports are entered manually by data entry contractors.

The electronic Medical Device Reporting (eMDR) project provides the capability for electronic data entry and processing of medical device adverse event reports. The project utilizes Health Level Seven (HL7) Individual Case Safety Report (ICSR) standard to receive medical device adverse events (MDRs). The eMDR application accepts electronic medical device reports via two options, designed for low and high volume reporters. Both options are open to all reporters.

(1) FDA eSubmitter – a free downloadable application that will allow submission of MDR reports one at a time. This option is suitable for low volume reporters. The software contains data elements from the current MedWatch and generates an HL7 ICSR message for each MDR the user generates using the software. See Technical Information on eMDR.

(2) Health Level 7 (HL7) Individual Case Safety Report (ICSR) – This option provides the capability to receive and process electronic MDR files either individually or as a batch and is particularly suitable for high volume reporters. Users of this option submit MDRs formatted as an HL7 ICSR message.

eMDR utilizes the FDA Gateway, an agency-wide entry point for all electronic submissions, to receive electronic MDRs. The Gateway authenticates and validates electronic submissions and routes it to CDRH. See the Electronic Submissions Gateway site to register as a trading partner. If you have any questions regarding the registration process or the Gateway in general, please contact the help desk as indicated on the website.