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# Regulatory Considerations for Dialysis Catheters
- URL: https://www.fdaweb.com/regulatory-considerations-for-dialysis-catheters/
- Published: 2018-10-16T12:00:00.000Z
- Updated: 2026-09-15T00:38:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142591

The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, FDA’s CDRH, academia, industry, and patient groups, intends to advance scientific understanding of kidney health and foster development of therapies for kidney diseases. The group’s Regulatory Considerations Affecting Device Approval project was designed to: **(1)** describe central venous catheters (CVCs) for hemodialysis; **(2)** identify common issues raised during reviews of FDA submissions; **(3)** identify the major benefits and risks of CVCs; **(4)** discuss recent technological advances for the devices; and **(5)** enumerate limitations of currently available technology requiring research or device modification.

The group says that CVCs for hemodialysis are necessary for a subset of patients with end-stage kidney disease. In an online [article](https://doi.org/10.2215/CJN.14251217?ref=fdaweb.com) in the *Clinical Journal of the American Society of Nephrology*, a workgroup says it hopes that improved understanding of the regulatory requirements for marketing devices will help foster device iteration and innovation, and result in more effective and safe devices for patients.