On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents,” explaining how a manufacturer distributing medical devices under an EUA or following a COVID-19-related enforcement policy guidance document can satisfy its associated adverse event (AE) reporting obligations. In general, each EUA or device-specific enforcement policy guidance document issued in response to the COVID-19 pandemic specifies the AE reporting requirements for manufacturers, and often user facilities, of the device(s) it covers. These requirements typically follow the standard medical device reporting (MDR) requirements established in 21 CFR Part 803, including the criteria for when an AE or malfunction is reportable and the timelines for reporting.
Accordingly, this updated policy represents a significant change for many firms that have stepped up to provide technologies during the COVID-19 public health emergency and that were not previously FDA-regulated medical device manufacturers. Those firms that are new to the medical device space would not have been previously subject to MDR obligations, and as such, would not have been expected to already have an electronic Medical Device Reporting (eMDR) account and processes for evaluating adverse events (AEs) and submitting MDRs. For those firms that are already submitting eMDRs outside of an EUA, this guidance does not add anything new to their existing obligations, but rather, makes clear that they should handle AEs and malfunctions for products that are marketed under an EUA according to the same process and requirements as other legally marketed medical devices.
Under a February 2014 final rule, medical device manufacturers and importers must submit MDRs to the FDA in an electronic format that the agency can process, review, and archive. FDA’s new FAQs explain how manufacturers can electronically submit an MDR for reportable adverse events; and how medical device establishments seeking to submit MDRs for a device available under EUA or following an enforcement policy guidance document for a COVID-19-related medical device can request an FDA Establishment Identifier (FEI) number, which is required to set up an account for submitting eMDRs. The FAQs make clear that FDA expects MDRs to be submitted electronically via an eMDR account by providing instructions for obtaining an FEI number as a first step to establishing the eMDR account. This is no small task, as the process for establishing an eMDR account can take days to weeks, including several rounds of back and forth with FDA to verify the establishment of a successful data link between the submitter’s system and FDA’s system. Detailed instructions for setting up an eMDR account can be found at FDA’s website at “Setting up a WebTrader Account Checklist.”
The FAQs also include general information on how to submit AE reports for devices distributed under an EUA or enforcement discretion policy. When submitting MDRs, the appropriate product code for the medical device in question must be used to ensure the MDR can be appropriately analyzed and minimize the need for follow-up from the FDA. The FDA’s product classification database can be used to search for the relevant product code for the medical device on which a report is being submitted, and the new FAQs provide a table listing product codes for some of the medical devices currently covered by existing EUAs or discussed in COVID-19-related guidances:
Note that there are many other products for which EUAs have been granted and for which there are corresponding Product Codes and this gap is not expressed in the FAQ.
The FAQs further indicate that FDA has made modifications to its eMDR system, which the agency had pledged to update by September. A full list of changes to the eMDR system is available on FDA’s enhancement page, and the list includes:
- Adding a field to the eMDR system, eSubmitter, and the Manufacturer and User Facility Device Experience (MAUDE) database to identify an MDR exemption number.
- New fields for summary reports, including a field for “Voluntary Malfunction Summary Reports,” as well as the number of summary events reported.
- Harmonizing adverse event codes with Adverse Event Reporting Terminologies from the International Medical Device Regulators Forum (IMDRF).
- Permitting the indication of whether a report is related to a drug-device combination product.
- Adding a field that allows submitters to include information on up to 20 drugs in a device-led combination product adverse event report.
- FDA also added two more fields to its MAUDE database: one for Patient Problem Codes, and one for Marketing Submission Number (for 510(k)s and PMAs).
Related to the ongoing COVID-19 pandemic, FDA had separately issued revised guidance in March on postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements; we summarized this guidance here.