Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access
- Published
- Sep 10, 2026
- Effective
- Sep 10, 2026
- Citation
- 91 FR 57498
- Docket
- Docket No. FDA-2026-N-9906
- Agencies
- DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
Final amendment; final order.
Summary
The Food and Drug Administration (FDA) has re‑classified devices that provide external support for an arteriovenous fistula used in dialysis access. Instead of being treated as higher‑risk “class III” products, these devices are now placed in “class II,” meaning they must meet specific performance and safety requirements—called special controls—identified by the agency. The FDA says this change will keep patients safe while making it easier for manufacturers to bring new, useful devices to market. The rule was issued by the U.S. Department of Health and Human Services, through the FDA, and it applies to companies that design, manufacture, or sell extravascular support devices for fistulas, as well as the hospitals and clinics that use them. By moving the devices to class II, manufacturers will generally need to submit a pre‑market notification (a 510(k) submission) that demonstrates compliance with the newly defined special controls. The regulation became effective on September 10, 2026, the same day it was published in the Federal Register (91 FR 57498). Because it is a final rule, the public comment period has already closed, and the FDA will now enforce the new classification. Manufacturers must adjust their product development and regulatory filings to meet the special controls, and the agency will review those submissions to ensure the devices remain safe and effective for patients.
AI-generated summary — verify against the Federal Register text.
Official abstract
The Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the extravascular support for an arteriovenous fistula for vascular access. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Topics
Track this rulemaking
Get alerts when this document changes status or its comment period closes, plus the bills that connect to it.
Sign up free