FDA review risk classification of absorbable haemostatic devices:
This article was originally published in Clinica
Executive Summary
The US FDA is proposing to down-classify absorbable haemostatic devices intended to staunch blood flow during surgery. These products are currently class III devices, requiring clinical trials, but have been on the market for several years and are now considered safe enough to move to class II, the agency announced on October 31. This will allow companies to file a 510(k) without studying their device in humans if they follow the premarket advice of a new proposed guidance document released on the same date. Comments are due by January 27.