FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; CARDIOVASCULAR DEVICES; CLASSIFICATION OF THE MECHANICAL DEVIATION DEVICE FOR ESOPHAGEAL PROTECTION DURING CARDIAC ABLATION PROCEDURES

WASHINGTON, Sept. 10 -- Food and Drug Administration has issued a rule called: Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures.

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 mechanical deviation device for esophageal protection during cardiac ablation procedures 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 mechanical deviation device...