FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; GENERAL HOSPITAL AND PERSONAL USE DEVICES; CLASSIFICATION OF THE WHOLE ROOM MICROBIAL REDUCTION DEVICE

WASHINGTON, Sept. 10 -- Food and Drug Administration has issued a rule called: Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device.

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 whole room microbial reduction device 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 whole room microbial reduction device. We are taking this action because we have determined that classifying t...