Adverse Event Reports for Devices Under an EUA

by Madison Green | Sep 18, 2020 | COVID-19, EU MDR, EUA, Pharmaceuticals, Quality, Recall, Regulatory, Risk Management

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 an account 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. If you 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.

¹FDA (January 2017) Emergency Use Authorization of Medical Products and Related Authorities Guidance Document retrieved on 09/10/2020 from: https://www.fda.gov/media/97321/download

²FDA (September ) Adverse Event Reporting for Medical Devices under Emergency Use Authorization retrieved on 09/10/2020 from: 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

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.