Zdrowie i gospodarka · 28/06/2013

Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the implanted blood access device preamendments class III device into class II (special controls) and subject to premarket notification, and to further clarify the identification. FDA is proposing this reclassification under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) based on new information pertaining to the device. This action implements certain statutory requirements.