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Compliance Sticker Shock May Await EUA Holders New to Device Space, BioWorld

Friday, March 12, 2021

Partner Dennis Gucciardo spoke with BioWorld about the hurdles medtech companies will likely face while converting their emergency use authorizations (EUAs) to conventional premarket filings. In the piece, he discussed issues that should be top of mind for device makers and actions the US Food and Drug Administration (FDA) may take under the Biden administration. One of the observations Dennis shared with BioWorld is that that while the FDA will give industry sufficient time to transition their 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.

Read the full BioWorld article >>