FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; CARDIOVASCULAR DEVICES; CLASSIFICATION OF THE EXTRAVASCULAR SUPPORT FOR AN ARTERIOVENOUS FISTULA FOR VASCULAR ACCESS

WASHINGTON, Sept. 10 -- Food and Drug Administration has issued a rule called: Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access.

The rule was published in the Federal Register on Sept. 10 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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...