The U.S. Food and Drug Administration (FDA) recently issued final guidance regarding the initiation of voluntary product recalls “to help companies prepare to quickly and effectively remove violative products from the...more
As we ring in the new year, it is time, once again, to reflect on the most significant legal developments for our drug and device clients this year. Below is a brief recap and assessment of our top-five developments impacting...more
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
As companies continue to produce, modify, and/or distribute essential medical equipment and supplies to support efforts to fight the COVID-19 outbreak, questions about whether these companies may be subject to liability...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