CDRH Industry: Implanted Blood Access Devices for Hemodialysis - Guidance for Industry and Food and Drug Administration Staff

A guidance document has been posted titled, 

"Implanted Blood Access Devices for Hemodialysis."  

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.