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FDA Cautions EUA-Holders They Have Same MDR Reporting Responsibilities As Other Manufacturers

In further sign the agency is tightening oversight of EUA products, regulators have set up a Q&A web page for manufacturers explaining their responsibilities to report adverse events.

Sign outside of FDA's headquarters in White Oak, MD

Manufactures that have an emergency use authorized (EUA) product on the market due to the COVID-19 pandemic are still bound by the same regulations as other device-makers to notify regulators about potential adverse events through the Medical Device Reporting (MDR) system.

The US Food and Drug Administration is reminding EUA-holders, some of whom don’t have a lot of prior experience with medtech regulations, that they are required to report adverse events...

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