Federal Register Notice: FDA is making available a guidance entitled Implanted Blood Access Devices for Hemodialysis. It was developed to support the reclassification of the implanted blood access devices for hemodialysis into Class 2 (special controls) and to assist industry in preparing premarket notification (510(k)) submissions for implanted blood access devices for hemodialysis. To download this guidance, click here. To view this notice, click here.
