Medical devices authorized under an Emergency Use Authorization (EUA) for COVID-19 must comply with adverse event reporting regulations similar to traditional devices, including reporting serious injuries and malfunctions. The submission of Medical Device Reports (MDRs) is required within specified time frames, with a focus on maintaining compliance even during the pandemic. Firms need to use the FDA's electronic reporting system for submissions, and assistance is available for those navigating the reporting process.

1. Adverse Event Reports for Devices under an EUA
By: Madison Wheeler
Hundreds of medical devices have been placed on the US market under an Emergency Use
Authorization (EUA) to aid in the fight against COVID-19. Much like other medical devices that
follow a more routine regulatory pathway, devices under an EUA must still comply with 21 CFR
803, including the submission of medical device reports (MDR’s) for reportable adverse events.
This regulatory requirement may not be explicitly clear to many of the non-med device firms
that stepped into the ring like Ford and Tesla.
Generally speaking, every medical device under an EUA must report the same adverse events as
traditional devices. This includes events such as deaths, serious injuries, and device-related
malfunctions that have, or may have, caused or contributed to a death or serious injury. Every
EUA includes conditions of authorization that specify the adverse event reporting requirements
for the device, so if the device is exempt from any type of reportable event it will be listed in the
accompanying EUA letter.1 The specified time frames for submitting MDR’s are the same for
traditional devices; so a firm must submit an MDR no later than 30 calendar days after
becoming aware of the event, or within 5 days for any events that require remediation action like
a device recall. The agency has made it clear that these timeframes are still strict requirements
even during the COVID-19 pandemic.
In order to submit an MDR, a firm must submit the report via the FDA’s Electronic Medical
Device Reporting (eMDR) system. Part of creating anaccount to submit an MDR via the portal
includes providing the manufacturer’s FDA Establishment Identifier (FEI), which is a unique
number received as part of the registration and listing process. If your establishment is not
required to register and list, but you have to submit an MDR, there is a way to request an FEI
from the FDA in order to do so. Additionally, healthcare workers and device consumers can
report problems to the FDA via the MedWatch online portal. The information submitted by
consumers can be leveraged to determine important safety information about the device and can
supplement information reported by manufacturers.2
Submitting an MDR can be a confusing process for even seasoned medical device firms. It is
important that not only all of the required information is accurately reported, such as product
code for the medical device, but also that it is submitted the right way. Ifyou have a medical
device on the market under an EUA and are worried about complying with the regulatory
requirements for adverse event reporting, EMMA International has the experience to help!
Contact us at 248-987-4497 or email info@emmainternational.com to get connected with our
team of regulatory experts.
1 FDA(January 2017) Emergency Use AuthorizationofMedical Products and Related Authorities Guidance Documentretrieved on09/10/2020
from: https://www.fda.gov/media/97321/download
2 FDA(September ) Adverse Event Reporting for Medical Devices under Emergency UseAuthorization retrieved on09/10/2020from:
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/adverse-event-reporting-medical-devices-under-emergency-
use-authorization-eua-or-discussed-covid-19