FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; GENERAL HOSPITAL AND PERSONAL USE DEVICES; CLASSIFICATION OF THE ACTIVE NOISE ATTENUATION SYSTEM FOR INFANT INCUBATORS

WASHINGTON, July 27 -- Food and Drug Administration has issued a rule called: Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators.

The rule was published in the Federal Register on July 27 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators 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 active noise attenuation system for infant incubators. We are taking this action...