> ## Content Index
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# CDRH Guidance on Implanted Blood Access Devices
- URL: https://www.fdaweb.com/cdrh-guidance-on-implanted-blood-access-devices/
- Published: 2016-01-20T12:00:00.000Z
- Updated: 2026-09-15T02:29:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134487

> CDRH has posted a [guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM308598.pdf?ref=fdaweb.com) on “Implanted Blood Access Devices for Hemodialysis” that provides recommendations for complying with special controls issued as part of a Center device reclassification from Class 3 to Class 2\. The devices are intended to provide access to a patient’s blood for hemodialysis. The document outlines the information recommended to be included in 510(k) submissions for such devices.