Zdrowie i gospodarka · 25/07/2014
Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
The Food and Drug Administration (FDA) is issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.