viernes, 22 de enero de 2016

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

A guidance document has been posted titled, 
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.

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