Tag: Premarket approval

Recently Posted FDA Guidance Documents

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 29, 2019. To view listings for other dates, see CDRH New – News and Updates. Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions This guidance document describes the Food and […]

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