IMPLANTABLE MECHANICAL/HYDRAULIC URINARY CONTINENCE DEVICE PMAs WILL NEED FIVE-YEAR STUDIES ON RISKS/BENEFITS; LONG-TERM POSTAPPROVAL STUDIES REQUIRED
This article was originally published in The Gray Sheet
Executive Summary
Premarket approval applications for implantable mechanical/hydraulic urinary continence devices should include studies with five-year follow-up data characterizing the "safety and effectiveness of the device over its expected lifetime," FDA says in a proposed rule calling for PMAs for the products.