FDA Loosens Controls on Two Gastroenterology-Urology Devices

The Food and Drug Administration is reclassifying implanted blood access devices (here) and implantable transporstatic tissue retractor systems (here) as Class II devices that do not require premarket approval, in two separate final orders issued July 25. Reclassification of the former takes effect July 25, while the latter's reclassification went into effect Sept. 13, 2013. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. Although they will no longer need FDA approval, both types of devices will still be subject to certain extra "special controls". They will not be exempt from premarket notification requirements.