FDA Loosens Controls on Pancreatic Drainage Devices

The Food and Drug Administration is formally reclassifying pancreatic drainage stent and delivery systems as Class II devices that do not require premarket approval, in an order that codifies a reclassification that took effect Dec. 18. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. But FDA reclassified them in response to a request from Xlumena, Inc. related to the AXIOS Stent and Delivery System. 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. pancreatic drainage systems will not be exempt from premarket notification requirements.