Edwards Lifesciences’ first-to-market transcatheter valve is safe and effective, and its benefits outweigh its risks in an expanded patient population, an FDA advisory panel says.
FDA’s Circulatory System Devices panel supported Edwards Lifesciences’ effort to expand labeling for its Sapien transcatheter heart valve replacement to patients at high risk when undergoing conventional open heart valve surgery.
The panel voted 10-2 June 13 that there was a reasonable assurance of safety and 12-0 that there was a reasonable assurance of effectiveness
The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.
The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.
States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.
