Issue Date: January 21, 2016
Issued by: Center for Devices and Radiological Health
Topic(s):
Status: Final
Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and Food and Drug Administration Staff
This guidance document provides recommendations for complying with special controls issued as part of the reclassification of Implanted Blood Access Devices for Hemodialysis into class II (special controls). The devices are intended to provide access to a patient’s blood for hemodialysis. FDA’s guidance documents, including this guidance , do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Download the Guidance Document
