The FDA has outlined the steps facilities using EUA medical devices should take to comply with AE reporting requirements electronically, Lexology.
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.
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