Federal Register #FDA-2026-N-9906

FDA Classifies Extravascular Support for AV Fistula as Class II Medical Device

This FDA final order addresses the classification of extravascular support devices for arteriovenous fistula (AVF) vascular access: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - Laminate Medical Technologies Ltd. (noted as device sponsor for VasQ) - Products/Devices: - Extravascular support for arteriovenous fistula for vascular access - Permanent implant, surgically placed outside or around an artery or vein - No specific part numbers or quantities provided - Unique/Notable Requirements: - Device classified as Class II medical device with special controls - Special controls include: - Clinical, animal, and non-clinical performance testing - Biocompatibility, sterility, and shelf life requirements - Detailed labeling requirements - Aims to ensure safety and effectiveness, reduce regulatory burdens, and improve patient access to innovative devices - This is not a procurement or award notice; no products or services are being requested

Description

The Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access into class II with special controls. This device is a permanent implant surgically placed outside or around an artery or vein to provide external support to arteriovenous fistulas created for vascular access by vascular surgery. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices. The special controls include requirements for clinical, animal, and non-clinical performance testing, biocompatibility, sterility, shelf life, and detailed labeling.

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