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# Guidance on Implanted Hemodialysis Devices
- URL: https://www.fdaweb.com/guidance-on-implanted-hemodialysis-devices/
- Published: 2016-01-21T12:00:00.000Z
- Updated: 2026-09-15T02:29:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134503

*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.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-21/pdf/2016-01094.pdf?ref=fdaweb.com)