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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.

Source: Federal Register — Food and Drug AdministrationOpen original release →