A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe...more
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