The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more
9/26/2019
/ Data Collection ,
FDA Approval ,
FDA De Novo Clearance ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
Medical Devices ,
Patient Access ,
Premarket Approval Applications ,
Transparency