FDA Loosens Controls on Hemostatic Sponges

The Food and Drug Administration is classifying nonabsorbable expandable hemostatic sponges for temporary internal use as Class II devices that do not require premarket approval, in an order that codifies a classification that took effect April 3. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. FDA is reclassifying them in response to a request from RevMedx related to its XSTAT device. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing, biocompatibility and labeling. They will not be exempt from premarket notification requirements.