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BioWorld - Friday, July 31, 2026
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Home » Compliance sticker shock may await EUA holders new to device space
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Compliance sticker shock may await EUA holders new to device space

March 12, 2021
By Mark McCarty
Most of the med-tech companies doing business during the COVID-19 pandemic are experienced and already have their FDA compliance systems in place. However, Dennis Gucciardo, a partner at the D.C. office of Morgan, Lewis & Bockius LLP, told BioWorld that while the FDA will give industry sufficient time to transition their emergency use authorizations (EUAs) to conventional premarket filings, the cost of setting up a quality management system may be greater than some current EUA holders are willing to bear.
Medical technology Regulatory Coronavirus U.S. FDA

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