CDRH New Update

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.govon August 29, 2019. To view listings for other dates, see CDRH New - News and Updates.

The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions - Guidance for Industry and Food and Drug Administration Staff  Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications - Guidance for Industry and Food and Drug Administration Staff