Table 2.

Vascular access products by the Food and Drug Administration center with regulatory jurisdiction

FDA Center and Review EntityDialysis Access–Related Product
Center for Devices and Radiologic Health
 Office of Device Evaluation, Division of Cardiovascular Devices, Vascular Surgery Devices BranchSynthetic (e.g., PTFE) AVGs; tissue AVG derived from animal (usually bovine) origin or human umbilical veins; stent grafts (covered stents); devices intended to assist in creating new AVF (e.g., via an endovascular approach); devices to assist in AVF maturation; devices to maintain or restore AV access patency
 Office of Device Evaluation, Division of Reproductive, Gastro-Renal and Urological Devices, Renal Devices BranchCentral venous catheters intended for hemodialysis; needles for AVF (and AVG); implanted needle guide devices
Center for Drug Evaluation and Research
 Division of Cardiovascular and Renal ProductsDrugs and therapeutic proteins intended to improve AVF maturation and function and reduce complications
Center for Biologics Evaluation and Research
 Office of Tissues and Advanced TherapiesTissue-engineered AVG (e.g., extracellular matrices developed through cell culture); cellular-, gene-, and tissue-based therapies intended to improve AVF maturation and function and reduce complications
  • FDA, US Food and Drug Administration; PTFE, polytetrafluoroethylene; AVG, arteriovenous graft; AVF, arteriovenous fistula; AV, arteriovenous.